REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676

General and Plastic Surgery Devices

1

No

(USA) including Indiana

Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits

Lot numbers: 13819779, 14002496, and 14356032

General and Plastic Surgery Devices

1

No

LA & KY

DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)

lot numbers 1143442 and 1161762

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.

DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 || Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing Lot #29000354.

Obstetrical and Gynecological Devices

1

No

Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebec, Canada, Japan, and Ireland.

DeRoyal Insufflation Tubing sets: || 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only || 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only || 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only || 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only || 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only || 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. || Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.

REF 89-5260.04, Lot Numbers: 17636582, 18080838, 18146577, 18178608, 18298693, 18952510, 19419055, 19480569, 19518336, 19592131, 19901141, 20128925, 20176492, 20678329, 20724372, 20822626, 21815858, 21923306, 22732536, 24157900, 24291754, 24630752, 24747336, 24823319, 25460353, 25721453, 25784489, 26018591, 26037952, 26149090, 26280549, 27163133, 27206527; REF 89-3928.10, Lot Numbers: 17826968, 17857924, 18177242, 18407790, 19021830, 19140417, 19676836, 20009408, 20127383, 20495653, 20676711, 20887981, 21023367, 21184339, 21531020, 21717131, 21839219, 22016935, 22057411, 22204397, 22379218, 22585169, 22731293, 23094151, 23420711, 23874561, 24230804, 24429928, 24519157, 24774801, 26098270, 26316468, 26663347, 26728235, 26956844, 27180961, 27343071, 27826304, 27911550, 27931729; REF 89-2960.20, Lot Numbers: 17903599, 17935806, 18183757, 19140610, 19325542, 19480673, 19881274, 20208693, 20679330, 20822829, 21056863, 21067909, 21318966, 21422472, 21649319, 21816375, 22123933, 22587164, 22782189, 23422927, 23696522, 23949622, 24007645, 24073423, 24232105, 24432131, 24468732, 24576258, 24823474, 26019527, 26281120, 26368444, 26785141, 26923452, 27227192, 27473916, 27931868

General and Plastic Surgery Devices

1

No

Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.

Sterile surgical kits containing the Umbilicup device: || DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-5260.04, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) VAGINAL DELIVERY TRAY, REF 89-3928.10, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) C-SECTION TRAY, REF 89-2960.20, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood

REF 89-7284.02: Lot Number: 26166359  REF 89-7237.01: Lot Number: 26013627  REF 89-7229.01: Lot number: 26013635  REF 89-5256.06: Lot Number: 26185242  REF 89-5277.02: Lot Number: 25793211  REF 89-6773.02: Lot Numbers: 25744022, 26010670, 26194641  REF 89-6196.03: Lot Number: 26097373  REF 89-7255.01: Lot Number: 26011736  REF 89-5275.05: Lot Number: 26063270  REF 89-5653.03: Lot Number: 26227422  REF 89-5654.03: Lot Number: 26020510  REF 89-5379.02: Lot Number: 26042735, 26282421  REF 89-5259.05: Lot Number: 25817201  REF 89-4718.04: Lot Number: 25840313  REF 89-4150.06: Lot Number: 25933077  REF 89-5317.02: Lot Number: 26078463  REF 89-3693.13: Lot Number: 26078447  REF 89-3694.13: Lot Number: 261449399  REF 89-6284.05: Lot Number: 25698986  REF 89-6285.06: Lot Number: 26078578  REF 89-6014.07: Lot Numbers: 26096856, 26147916  REF 89-3330.05: Lot Number: 26078367  REF 89-3331.04: Lot Numbers: 25817383, 26019720  REF 89-6467.05: Lot Number: 25880438  REF 89-6776.04: Lot Number: 26010688  REF 89-5257.08: Lot Numbers: 26125434, 26149102  REF 89-3479.08: Lot Numbers: 25873676, 25905092  REF 89-2910.09: Lot Number: 25695611  REF 89-6720.01: Lot Number: 26022048  REF 89-6629.01: Lot Number: 25839187  REF 89-2650.15: Lot Numbers: 25893423, 26010207, 26077111  REF 89-2644.17 A & B: Lot Number: 25894012  REF 89-6994.02: Lot Number: 25853544  REF 89-6996.02: Lot Number: 25853608  REF 89-6991.02: Lot Number: 25696032  REF 89-6998.03: Lot Number: 25853587  REF 50-4157.29: Lot Number: 25732507  REF 50-13010.19: Lot Number: 26009978  REF 89-6883.02: Lot Number: 25695911  REF 89-5382.03: Lot Number: 26020464  REF 89-3389.11: Lot Number: 26010291  REF 89-7114.02: Lot Number: 26012780  REF 89-7660.01: Lot Number: 26022656  REF 89-7549.02: Lot Numbers: 26042330, 26147713  REF 89-7546.02: Lot Numbers: 26025242, 26025717  REF 89-7536.02: Lot Number: 26022161  REF 89-7500.02: Lot Number: 26096063  REF 89-7495.02: Lot Number: 26256371  REF 89-7486.02: Lot Number: 26100624  REF 89-7484.01: Lot Number: 25875196  REF 89-7466.01: Lot Number: 26013301  REF 89-7465.03: Lot Number: 26096039, 26166244  REF 89-7451.02: Lot Number: 26166252  REF 89-7396.01: Lot Number: 26061573  REF 89-7448.03: Lot Number: 26166236  REF 89-7446.02: Lot Number: 26096549  REF 89-7365.01: Lot Numbers: 25838838, 26095765  REF 89-7357.01: Lot Number: 25874821  REF 89-7353.01: Lot Number: 26013862  REF 89-7327.02 & .03: Lot Numbers: 26012878, 26061611  REF 89-7326.02: Lot Number: 26013791  REF 89-6466.03: Lot Number: 26064133  REF 89-7198.02: Lot Numbers: 26011461, 26114751  REF 89-7192.02: Lot Number: 26013061  REF 89-7179.03: Lot Number: 26012229  REF 89-7177.03: Lot Number: 26061362  REF 89-7163.01: Lot Numbers: 26013299, 26114794  REF 89-7102.02: Lot Numbers: 25941536, 26011453  REF 89-7103.02: Lot Number: 26062031  REF 89-7105.03: Lot Numbers: 25941704, 26061371  REF 89-7117.01: Lot Numbers: 25744508, 25957301, 26095722  REF 89-7070.02: Lot Number: 26042137  REF 89-7029.02: Lot Number: 26011331  REF 89-7020.02: Lot Number: 26012704  REF 89-7076.03: Lot Numbers: 26012755, 26095749  REF 89-7069.01: Lot Number: 25814941  REF 50-13042.12: Lot Number: 25839929  REF 50-13200.13: Lot Number: 25878602  REF 89-6868.02: Lot Number: 25838731  REF 89-7001.03: Lot Numbers: 25854070, 25765333  REF 89-7011.02: Lot Number: 25853341  REF 89-7146.01: Lot Number: 26096186  REF 89-7185.01: Lot Number: 26011832  REF 94-0093.11: Lot Number: 26185197  REF 94-0097.11: Lot Number: 26136601  REF 89-7665.02: Lot Numbers: 26016318, 26097592  REF 89-7661.01: Lot Number: 26077698  REF 89-5113.09: Lot Number: 26018452  REF 89-7116.01: Lot Number: 26012712  REF 89-3695.13: Lot Numbers: 26042701, 26099432  REF 89-5396.03 A & B: Lot Number: 25792577  REF 89-6697.03: Lot Numbers: 25696067, 26146690  REF 89-7113.03: Lot Number: 25874231  REF 89-4164.06: Lot Number: 26098608  REF 89-4612.06: Lot Number: 25647601  REF 89-5720.02: Lot Number: 25746298  REF 89-6428.01: Lot Numbers: 25699111, 26021547  REF 89-6352.03: Lot Number: 26100026  REF 89-6348.03: Lot Number: 26021336  REF 89-6798.01: Lot Number: 25838686  REF 89-6799.01: Lot Number: 26094906

General and Plastic Surgery Devices

1

No

Nationwide Distribution.

Sterile surgical kits: || DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; || DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; || DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; || DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; || DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; || DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; || DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; || DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; || DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; || DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; || DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; || DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; || DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; || DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; || DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; || DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; || DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; || DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; || DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; || DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; || DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; || DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; || DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; || DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; || DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; || DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; || DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 || DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; || DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; || DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; || DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; || DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; || DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; || DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; || DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; || DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; || DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; || DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; || DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; || DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; || DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; || DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; || DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; || DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; || DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; || DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; || DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; || DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; || DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; || DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; || DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; || DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; || DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; || DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; || DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; || DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; || DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; || DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu

REF 89-7617.01: Lot Number 23700991; REF 47-003: Lot Numbers: 19930881, 14034148, 15104953; REF 47-094.019: Lot Number 20508661, REF 47-276.13: Lot Numbers: 17602649, 19555209, 20376793, 21093681, 22419187, 22683210, 24979698; REF 47-324: Lot Numbers: 17889221, 18103956, 18198174, 18782311, 19462176, 19930911, 20508688, 20841051, 21885303, 22898544, 23264965, 23909381, 24461442, 24721435, 24826376, 24870174, 24926879, 25051242; REF 47-327: Lot Numbers: 17830692, 18507723, 20434261, 20504978, 20689600 20796333; REF 47-483: Lot Numbers: 14128591, 18477552, 18871373, 19042121, 19251900, 19990972, 20189171, 20795058, 21097260, 24023557, 24095500, 24174697, 24203283, 24248043, 24808987; REF 47-491.12: Lot Numbers: 17784008, 18987974, 21361438, 22373001, 22772933, 22947297; REF 47-600: Lot Numbers: 17094939, 17217214, 17243463, 17538026, 17738634, 18550713, 18982727, 19491612, 20576681, 20597545, 20779787, 20873001, 21667226, 22195671, 22830380, 23278187, 24059576, 24220391; REF 47-626: Lot Numbers: 17227623, 17295327, 18507766, 18521306, 19310383, 19930953, 20503570, 21092194, 21521083, 22373043, 23251232, 23904248; REF 47-670.05: Lot Numbers: 17022468, 17390957, 18563750, 18755903, 19668318, 19930961, 21474248, 21617051, 22142755, 24310871; REF 47-743.01: Lot Numbers: 17841990, 18452507, 19327100, 19703814, 20178308, 21924659, 22354192, 22900561, 24311516, 24663458, 24924136; REF 47-777.02: Lot Numbers: 17594853, 17832541, 18987982, 19010591, 19313040, 19584712, 21339177, 21821158, 22934681, 23705839, 23846199, 24809496; REF 50-3474.02: Lot Numbers: 18588210, 19507080; REF 89-3899.01: Lot Numbers: 17880972, 18177197, 18691938, 18710967, 18909781, 19021821, 19213727, 19323002, 19517270, 19879799, 20009395, 20207308, 20495637, 21055140, 21317453, 21827031, 21839201, 22057382, 22731285, 22849558, 23336324, 23531023, 23778991, 24005738, 24746747, 24822480; REF 89-6306.02: Lot Numbers: 17682829, 17781843, 17884746, 19328381, 19569264, 19845329, 19883659, 20013571, 20371095, 20894128, 21500557, 21687016, 21841853, 22059839, 22736449, 23621889, 23879134, 24009798, 24294533, 24521222; REF 89-7650.01: Lot Number 24631085; REF 47-746.04: Lot Numbers: 17283351, 17537736, 17669261, 17796391, 18493296, 18750635, 18958621, 18982583, 19407302, 19690523, 20547257, 20597916, 20662280, 20936851, 21149437, 21544832, 21666944, 21707355, 21775500, 23074715, 23683203; REF 47-501: Lot Numbers: 18507758, 18521293, 18624479, 19555225, REF 47-004: Lot Numbers: 22898536, 17138831, 18755831, 20697511, 21116791; REF 47-751: Lot Numbers: 18429569, 19668529

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Kits and Trays containing alcohol swabstick/prep pad: || GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 || Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA

REF 50-11656.02: Lot Number 19321517

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.

REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers: 28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and 25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275, 26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957, 25068811

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Non-sterile wound closure strips, packaged as follows: || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-204N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849

REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374, 25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF 47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47-732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47-787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 50-7104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 50-7195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324, 26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 50-9786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361, 25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers: 26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297, 26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537, 24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103, 26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521; REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440, 26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713, 26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448, 26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 89-0323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721, 27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345, 25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439, 26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 89-2703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775, 25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911, 25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710, 27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921, 26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103, 25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 89-3190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100, 25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers: 27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134; REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458, 26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 89-3472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218, 27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458, 25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579; REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684, 27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504, 26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507, 25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374, 26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006, 25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821, 26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers: 25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541, 27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786, 25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF 89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174, 25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633, 25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575; REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007, 25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969, 26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044, 27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers: 27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433, 27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258, 25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523, 27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033, 26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639, 24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759, 27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446, 27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023, 26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050, 26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522, 27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306, 25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069, 26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers: 26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150; REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735, 26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers: 27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602, 26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946, 24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers: 27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249; REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848, 25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236, 26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921, 25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061, 25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598, 26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 89-5901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268, 27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010, 24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900, 26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044, 25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers: 27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 89-6478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450, 26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071, 24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985, 25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111, 26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 89-6724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838, 24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842, 25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers: 27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021, 26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751, 27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101, 26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234, 24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251, 26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419, 27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977, 25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752, 26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795, 25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242, 26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671; REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485, 26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109, 27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821, 26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137, 25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191, 25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528, 26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902, 24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116, 26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 89-7613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696, 27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620, 26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410, 25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501; REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers: 26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741, 26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers: 27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912, 28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491, 26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436, 25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 89-6371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682, 25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344; REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560, 26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 89-6717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460, 27981494, 28016813, 28039

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Sterile sterile surgical kits containing Episeal products, packaged as follows: || DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal MINOR INTERVENTIO

REF 46-202, Lot Number: 346935; REF 46-203, Lot Numbers: 345495, 362263; REF 46-204, Lot Numbers: 350142, 344274; REF 46-206, Lot Numbers: 342708, 2360103; REF 46-212, Lot Numbers: 352631, 345230; REF 46-213, Lot Number: 350152; REF 46-214, Lot Numbers: 344278, 345232; REF 46-215, Lot Number: 345242; REF 46-216, Lot Numbers: 585961, 350276

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Sterile wound closure strips, packaged as follows: || DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-203, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-204, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-206, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-212, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-213, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-214, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-215, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-216, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849

RES 47-763.02, Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527  RES 47-773, Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745  RES 50-12437.08, Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765  RES 89-6818.01, Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296  RES 89-5649.01, Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531   RES 32-1695, Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758  RES 32-351, Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430  RES 89-6752.01, Lot Numbers: 20835339, 21511803, 23485821  RES 89-7212.01, Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321

General and Plastic Surgery Devices

1

No

Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.

DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 || DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 || DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 || DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 || DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 || DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 || DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 || DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20835339, 21511803, 23485821 || DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321 || Custom Surgical kits.

31-702: 18040107, 18125741, 18150322, 18368014, 18605067, 18605067, 19032694, 19032694, 19136741, 19557491, 20023453,  20102637, 20190729, 20190729, 20023453, 20190729, 20510139, 20023453, 20190729, 21049840, 21049840, 21517201, 21780683, 21780683, 21517201, 21780683, 22025604, 22147169, 21517201, 21517201, 22269799, 22952133, 23474014, 23474014, 23474014, 24194532, 24194532, 24406620, 17950117, 19136741, 21517201, 21780683, 22147169, 22025604, 22595121, 23918771, 24406620, 20190729, 18040107, 18605067, 19032694, 19136741, 20190729, 18150322, 19032694, 20102637, 20190729, 20190729, 21517201, 22269799, 22269799, 24406620, 24406620, 17296856, 17950117, 18368014, 18368014, 18368014, 18605067, 19557491, 19557491, 20510139, 20634166, 21168988, 22952133, 22595121, 22898042, 22952133, 22269799, 24194532, 24194532, 24406620, 19557491, 19032694, 19032694, 20023453, 20023453, 20190729, 20510139, 20634166, 21517201, 21517201, 21517201, 22898042, 21517201, 23918771, 18040107, 18605067, 20023453, 20634166, 21049840, 21168988, 21517201, 22595121, 17950117, 17296856, 19136741, 19032694, 20190729, 20190729, 20190729, 20190729, 20190729, 20023453, 20634166, 21517201, 22025604, 21517201, 21517201, 23918771, 17950117, 18040107, 18368014, 18605067, 18605067, 19032694, 19218034, 19136741, 19557491, 20190729, 20190729, 20190729, 20510139, 21049840, 21049840, 21517201, 21780683, 22025604, 21517201, 21517201, 21517201, 21517201, 22952133, 22595121, 21517201, 23918771, 23474014, 24194532, 23474014, 24892314, 24194532, 22025604, 18040107, 18125741, 18368014, 18605067, 19032694, 19136741, 19218034, 20023453, 20102637, 20190729, 20190729, 20510139, 20634166, 21168988, 21517201, 21588464, 21517201, 20634166, 21517201, 21780683, 22025604, 22595121, 21517201, 22269799, 23474014, 24194532, 24194532, 20023453, 20190729, 20634166, 22595121, 22898042, 21517201, 23474014, 24641355 31-704: 17407430, 18395135, 18605075, 18605075, 19476391, 19476391, 19557520, 20510155, 20914037, 21049866, 21238801, 1397561, 21588481, 21746987, 22269810, 23474022, 23474022, 23750736, 23750736, 24406638, 24406638, 24406638, 17407430, 17407430, 17407430, 17950133, 18234024, 18395143, 18368031, 18368031, 18368031, 18605075, 18962021, 18962021, 18605075, 18962021, 18605075, 18962021, 18605075, 19089121, 19089121, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 19557520, 19792802, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20510155, 20656576, 20914037, 21049866, 20656576, 21049866, 21049866, 21238801, 21238801, 21397561, 21588481, 21588481, 21588481, 21746987, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22758218, 22269810, 23192682, 23192682, 23474022, 23474022, 23750736, 23474022, 23750736, 24175892, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 17950133, 18234024, 18368031, 18368031, 18368031, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 19476391, 19792802, 19557520, 19557520, 20510155, 20656576, 20656576, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21588481, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22758218, 22269810, 23474022, 23750736, 23750736, 23750736, 24175892, 23750736, 24175892, 24175892, 24175892, 24175892, 24406638, 24175892, 24175892, 24406638, 24406638, 24764187, 22269810, 18962021, 17407430, 18234024, 18234024, 18368031, 18395135, 18605075, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 17407430, 18234024, 19089121, 18605075, 19476391, 20510155, 20656576, 21397561, 21588481, 21588481, 21746987, 22531646, 22758218, 22269810, 22269810, 23192682, 23474022, 23192682, 23474022, 24406638, 24764187, 18605075, 19089121, 19476391, 19557520, 19792802, 20510155, 20914037, 21049866, 21049866, 21049866, 21238801, 23750736, 24406638, 24406638, 24406638, 23192682, 18962021, 21049866, 21588481, 23750736, 17407430, 17950133, 18234024, 18234024, 20510155, 21049866, 21238801, 21746987, 22037111, 20914037, 18605075, 23474022, 22758218, 17407430, 17407430, 17407430, 17950133, 17950133, 18234024, 18368031, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 18962021, 18605075, 18962021, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 20510155, 20510155, 19557520, 20510155, 20656576, 20656576, 20914037, 20914037, 20656576, 20656576, 21049866, 21049866, 21506318, 21746987, 21746987, 22037111, 22037111, 22269810, 22758218, 22758218, 22758218, 22269810, 22269810, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23474022, 23474022, 23474022, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 24406638, 21397561, 22269810, 23474022, 23750736, 24175892, 24764187, 19792802, 17407430, 17950133, 18234024, 18395143, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19792802, 19557520, 19557520, 19792802, 20510155, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20656576, 21238801, 21506318, 21397561, 21397561, 21588481, 21397561, 22037111, 22531646, 22531646, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23474022, 23750736, 23750736, 24175892, 24175892, 23750736, 24406638, 24406638, 24406638, 24406638, 24764187, 23192682, 17407430, 18605075, 18605075, 18605075, 19476391, 19476391, 20510155, 20914037, 21506318, 21588481, 22037111, 22758218, 22269810, 23474022, 23750736, 24175892, 24764187, 17950133, 18234024, 18368031, 18234024, 18605075, 19089121, 19089121, 18605075, 19476391, 1792802, 19557520, 20510155, 20510155, 20510155, 20914037, 21238801, 21238801, 21506318, 21397561, 21588481, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22758218, 22269810, 22758218, 22269810, 22531646, 23192682, 23192682, 23750736, 23750736, 24175892, 24175892, 24764187, 18605075, 17950133, 17950133, 18395143, 18368031, 18962021, 18605075, 19089121, 18605075, 19476391, 18605075, 19557520, 19557520, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21588481, 21746987, 22269810, 22531646, 22758218, 22269810, 23192682, 23474022, 23750736, 24406638, 24406638, 24406638, 24764187, 19476391, 21049866, 22037111, 17950133, 18395143, 18368031, 18605075, 17950133, 18368031, 18605075, 19089121, 19476391, 19557520, 20510155, 20656576, 21238801, 21397561, 21588481, 21746987, 22037111, 22758218, 22758218, 23192682, 23750736, 24175892, 24406638, 18605075, 20510155, 20510155, 20656576, 21049866, 21049866, 21746987, 21746987, 22269810, 23192682, 23192682, 24406638, 17950133, 18368031, 18605075, 19792802, 20510155, 20914037, 21049866, 21397561, 21588481, 21588481, 21588481, 22269810, 23192682, 23192682, 23192682, 23474022, 23750736, 24175892, 24175892, 24406638, 24764187, 24764187, 18234024, 18234024, 18234024, 18234024, 18962021, 19089121, 19476391, 19476391, 19557520, 19557520, 20510155, 20510155, 20510155, 22758218, 23750736, 19476391, 19089121, 19476391, 19089121, 19476391, 20510155, 20510155, 20656576, 21238801, 18605075, 22531646, 22758218, 20656576, 22037111, 17407430, 17950133, 18395143, 18234024, 18368031, 18368031, 18605075, 18605075, 18605075, 18605075, 18605075, 18962021, 19089121, 18962021, 18605075, 18605075, 19476391, 19476391, 19089121, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20510155, 20914037, 20914037, 18234024, 20656576, 20914037, 21049866, 21049866, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21397561, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23750736, 23750736, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24406638, 24764187, 17407430, 23192682, 23474022, 24175892, 24175892, 21397561, 21588481, 21746987, 22037111, 22037111, 22269810, 22269810, 22269810, 22531646, 22269810, 23474022, 24406638, 24764187, 24406638, 24764187, 17407430, 18234024, 18368031, 18395135, 18395135, 18605075, 18605075, 18962021, 18962021, 18962021, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21506318, 17950133, 17950133, 17950133, 18234024, 18368031, 18605075, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20656576, 20914037, 20914037, 24406638, 24764187, 18962021, 19476391, 19792802, 19792802, 20510155, 20656576, 21588481, 21746987, 22037111, 22531646, 23192682, 23474022, 23750736, 18234024, 19476391, 21238801, 22037111, 23192682, 24175892, 21397561, 21746987, 22531646, 22269810, 23474022, 24175892, 21049866 31-938: 18368057, 17070224, 17407448, 17407448, 18368057, 20656584, 21588499, 22147193, 20510180, 21747007, 24194559, 18500214, 20656584, 22269836, 23750744, 21747007, 24046927, 24194559, 24406646, 20069646, 21672797, 21672797, 18368057, 24406646, 17407448, 17407448, 18368057, 18500214, 18500214, 18500214, 19089148, 19089148, 19089148, 19089148, 19089148, 18500214, 20069646, 19940879, 20069646, 20510180, 20656584, 20656584, 20656584, 20069646, 20510180, 21672797, 21747007, 21747007, 21907509, 22147193, 22269836, 21907509, 22269836, 22853565, 21747007, 21907509, 23382419, 23750744, 24046927, 24194559, 24406646, 24194559, 17407448, 18500214, 18500214, 19089148, 20069646, 19940879, 20656584, 21672797, 22269836, 23750744, 19089148, 20656584, and 22269836.

General Hospital and Personal Use Devices

1

No

Nationwide Distribution

Lubricating Jelly packaged as follows: || (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; || (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; || (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA || Lubricating body orifices.

Lot number 13063705

General and Plastic Surgery Devices

1

No

LA & KY

DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

Lots: 47001, 49894, and 51311

Physical Medicine Devices

1

No

US Nationwide Distribution

PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, || Product Usage: || Lateral and medial epicondylitis

Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441

Physical Medicine Devices

1

No

US Nationwide Distribution

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, || Product Usage: || Lateral and medial epicondylitis

REF 50-13272.05; Lot Numbers: 17739282, 18176434, 18472233, 18812517, 19020546, 19187135, 19516744, 20175043, 20429998, 20494394, 20886460, 22346424, 22730047, 22821900, 23335313, 23615260, 24004698, 24338081; REF 89-5721.02; Lot Numbers: 17637745, 18026233, 18026241, 18081398, 18120801, 18120836, 18137363, 18179580, 18270594, 18336750, 18692682, 19052599, 19520209, 19684545, 19703890, 20210291, 20561454, 20893416, 21412776, 21559479, 22188024, 23002893, 23340948, 23534654, 23951183, 24294226; REF 89-6353.03; Lot Numbers: 16174769, 16174793, 16174806, 16407833, 18271167, 18410809, 18497262, 18639208, 18661122, 18867024, 19103261, 20501056, 21186406, 21652702, 22059951, 22124741, 22736713, 23699328, 24075699, 24233677, 24868171; REF 89-6425.03; Lot Numbers: 19569432, 19569459, 19569467, 19623929, 19686014, 19686022, 20502260, 20683970, 20895518, 21113186, 21375258, 21653650, 22021363, 22060434, 22188585, 22319101, 22437431, 22737661, 22924175, 23427461, 23623083, 23880590, 24010895, 24162493, 24578659, 24750594, 24827723; REF 89-6428.01; Lot Numbers: 16808282, 18591611, 18867534, 18966006, 19685476, 20013925, 20040771, 20179255, 20501427, 20894777, 21112933, 21653019, 22020889, 22083361, 22188323, 22506272, 22737020, 23235996, 23535711, 24076018, 24294955, 24578341, 24600617, 24776524; REF 89-6431.03; Lot Numbers: 17885503, 18146825, 18271491, 18411051, 19521041, 19685661, 19778242, 19824819, 20133118, 20179360, 20683460, 21058973, 21375178, 21653297, 22021110, 22188446, 22437246, 22590021, 22737273, 22965031, 23236180, 23236198, 24076237, 24162160, 24600692, 24827230; REF 50-12770.12; Lot Numbers: 17679267, 18007518, 18078455, 18104844, 18495216, 18810706, 19018489, 19186749, 19568595, 19673598, 19727656, 19776191, 20006637, 20173700, 20884270, 21053081, 21529018, 21813019, 21881433, 21978198, 22203811, 22286821, 22412612, 22582822, 22609440, 22821601, 23945445, 24229150, 24427324, 24745082, 25022978; REF 50-13049.13; Lot Numbers: 17634000, 17879841, 18495689, 18812365, 19900463, 20231404, 21054315, 21530211, 21645502, 22082107, 22261957, 22729986, 23198435, 23419488, 23777947, 24428845, 24853981; REF 50-5297.12; Lot Numbers: 17434198, 17902941, 18075895, 18183116, 18408725, 18452056, 18496729, 18496737, 18677440, 19023739, 19419805, 19496704, 19681168, 19901562, 20176901, 20232423, 20678855, 20890573, 21513260, 21648922, 21923568, 22018201, 22082828, 22586858, 22822451, 22938892, 23233202, 23422521, 23532552, 23838199, 24073247, 24158304, 24431770, 24575976, 24854916; REF 50-8069.03; Lot Number 17701102; REF 50-9269.02; Lot Numbers: 17374463, 18108933, 18217259, 18405153, 18495005, 18856691, 19412419, 19672253, 20283909; REF 50-9329.21; Lot Numbers: 18910336, 19023851, 19419987, 19681715, 19828861, 19869970, 20011356, 20232491, 20461154, 20679014, 20758054, 22610547, 22757282, 22822486, 22872547, 23422679, 23532683, 24369064, 24576047, 24775329, 24806789; REF 53-1930.01; Lot Numbers: 24884461, 25014468, 25015428, 25055227; REF 53-1736.06; Lot Numbers: 18118058, 18118066, 18118074, 18272995, 18273015, 18273023, 18339678, 18339686, 18339694, 18421006, 18421014, 18421022, 18539830, 18539848, 18564509, 18564517, 18564525, 18656438, 18656446, 18782004, 18782012, 18782021, 18871023, 18871031, 18871040, 18871058, 18969944, 18969952, 19030736; REF 89-0882.10; Lot Numbers: 17964092, 18074788, 18273912, 18341073, 18405188, 18676631, 19447902, 19672333, 19800294, 20230920, 20882573, 21003711, 21109267, 21314981, 21528058, 21642011, 22231475, 22788783; REF 89-2156.07; Lot Numbers: 17901420, 18074796, 18217304, 18273921, 18495072, 18533551, 18657094, 18809078, 19016707, 19412591, 20004720, 20036924, 20172942, 20491214, 20911928, 21109312, 21642070, 21861408, 22392981, 22727358, 22937611, 23416332, 23775790, 24002393, 24517709; REF 89-2422.11; Lot Numbers: 17615714, 18049857, 18217312, 18341137, 18495099, 18586302, 18809094, 19186474, 19412603, 19672413, 20004771, 20369948, 21052248, 21812331, 21861432, 22013646, 22034877, 22081788, 22581774, 22937638, 23416359, 24287093, 24426410; REF 89-2670.12; Lot Numbers: 17913404, 18214998, 18553674, 18861263, 19068751, 19417181, 19828342, 20008958, 20494968, 21054729, 21385860, 21530641, 21814521, 22140864, 22394012, 22636931, 23055274, 23335727, 23778270, 23873939, 24156296, 24356044, 24429477, 24795389; REF 89-2671.14; Lot Numbers: 17880340, 18176565, 18215000, 18451467, 18620478, 18861271, 19068769, 19187338, 19322405, 19417199, 19676254, 19777004, 20008966, 20231931, 20675911, 20712890, 20782118, 20887155, 20912390, 21004490, 21297552, 22016311, 22394021, 22730637, 22871501, 23188333, 23420008, 23470865, 23693778, 24230329, 24518971, 24662105; REF 89-2688.08; Lot Numbers: 17347676, 18183440, 18474301, 18497019, 18815751, 19044222, 19325825, 19642513, 19881493, 20011751, 21005370, 21457907, 21649597, 22058721, 22100969, 22347101, 24576477; REF 89-2817.07; Lot Numbers: 17964519, 18029725, 18183511, 18183520, 18712743; REF 89-3064.07; Lot Numbers: 17463167, 17617699, 18183909, 18342439, 18474212, 18712567, 19325649, 19881354, 20208781, 21005302, 21056919, 24102984, 24650825; REF 89-3129.02; Lot Numbers: 21649431, 21875543, 22177165, 22347048, 22624308; REF 89-3145.10; Lot Numbers: 17901489, 17974266, 18181524, 18283766, 18405241, 18469878, 18553033, 18586361, 18907831, 18977549, 19050219, 19150578, 19336621, 19447937, 19479058, 19514554, 19672499, 19810038, 19876838, 20204756, 20491329, 20537665, 20672015, 20818504, 20882805, 20954240, 21052299, 21143852, 21182907, 21421138, 21469924, 21642176, 22013718, 22013726, 22122666, 22260954, 22377001, 22434150, 22581871, 22727471, 22780571, 22917725, 23222255, 23416455, 23527817, 23775896, 24002529, 24287165, 24426495, 24572695, 24744274, 24896913; REF 89-3251.08; Lot Number 18008035; REF 89-3179.01; Lot Numbers: 17663337, 17880518, 18176725; REF 89-3423.03; Lot Numbers: 17348273, 17617912, 17643336, 18474431, 19196509, 19326001, 19683147, 20392777, 20498651, 21005425, 21319281, 22018789, 22399454, 24243859; REF 89-3448.03; Lot Numbers: 17481461, 17877520, 18135499, 18349606, 18406252, 18587014, 18858697, 18951841, 19050753, 19414289, 19751875; REF 89-3802.04; Lot Numbers: 17904399, 17904401, 18014081; REF 89-3805.12; Lot Numbers: 17739493, 17780568, 17841906, 17989038, 18456348, 18475240; REF 89-3825.13; Lot Numbers: 17779698, 17988481, 18025821, 18080070, 18177146, 18269219, 18335482, 19021776, 19101311, 19131633, 19322915, 19715410, 20009361, 20325638; REF 89-3861.10; Lot Numbers: 16404894, 17635168, 18861861, 19322958, 20207252, 21004705, 21055115, 24932241; REF 89-4260.08; Lot Numbers: 19022103, 19323344, 19337851, 19517501, 19677142, 20009598, 21647065, 22244452, 22346678, 22981364, 23066571, 23230626, 23779272, 24072076, 24519202, 24575001, 24854457; REF 89-4272.03; Lot Numbers: 17635467, 18155668, 18177550, 18473113, 18862135, 19225402, 20495952, 21947156, 22057665, 22585311, 24006061, 24290903; REF 89-4340.02; Lot Numbers: 17881351, 18177605, 18384760, 18473201, 18559961; REF 89-4401.01; Lot Numbers: 6514997, 17349170; REF 89-4431.04; Lot Numbers: 17477631, 17672209, 17802106, 18029320, 18181778, 18274000, 18525593, 18535484, 18535492, 18659209, 18862266, 19022322, 19101581, 19418263, 19517755, 19801385, 19915761, 20009791, 20207746, 20370498, 20496226; REF 89-4811.07; Lot Numbers: 18474829, 18864595, 19326490, 19519224, 20177858, 20499232, 20758492, 21057541, 21816834, 22019221, 22187638, 22216275, 22414079, 22470708, 22734718, 22922209, 23234256, 23620165, 23950383, 24025641, 24074178, 24253942, 24293338; REF 89-5197.01; Lot Numbers: 15836855, 18178552, 18473949, 19383451, 19518299, 20010492, 21338713, 21686777, 21840084, 22058393, 22732464, 22872230, 23015504, 23189424, 23258987, 23337685, 23532026, 23948777; REF 89-5434.03; Lot Numbers: 17964711, 18077401, 18185912, 18343247, 18691268, 18857029, 19017013, 19318756, 19514722, 19877048, 20491492, 20883111, 21315221, 21642504, 21837133, 22377191, 22917987, 23222651, 23690825.23944784, 24287333, 24517848; REF 89-5579.02; Lot Numbers: 17905623, 18001298; REF 89-5645.01; Lot Numbers: 17857991, 18475531, 18816964, 19120900, 21023957, 21599147, 21651582, 21817263, 21841360, 22059530, 23066985; REF 89-5702.01; Lot Numbers: 17882978, 18179184, 18475670, 18911144, 19026121, 19214851, 19327425; REF 89-5747.04; Lot Numbers: 17883330, 17989476, 18137241, 18270471, 18410104, 18410112, 18536891, 18660496, 18817473, 18896001, 19032969, 19033321, 19033339, 19033347, 19033355; REF 89-5753.03; Lot Numbers: 17781051, 17931549, 18081283, 18137275, 18179432, 18336602, 18475944, 18817529, 18896010; REF 89-5907.01; Lot Numbers: 15560924, 15817321; REF 89-5952.02; Lot Numbers: 17632012, 17679531, 17878151, 17929852, 17987358, 18078834, 18175247, 18268030, 18334316, 18406615, 18406631, 18450958, 18471370, 18534385, 18587276, 18709667, 18859180, 18931356, 19019060, 19050913, 19151642, 19248701, 19414908, 19414916, 19515856, 19878366, 20037687, 20492971, 20673923, 21004043, 21315853, 21470520, 21644235, 21921618, 22014913, 22056443, 22122965, 22272269; REF 89-6003.01; Lot Numbers: 17901761, 18013643, 18182017, 18405524, 18533841, 18857416, 19050374, 19413198, 19590557, 19672907, 19776028, 19877419, 20037206, 20378828, 20537905, 20712241, 20883509, 21052707, 21315360, 21528613, 21837361, 22055862, 22377458, 22727905, 22870509, 23066256, 23223071, 23612739, 24287632; REF 89-6060.02; Lot Numbers: 17347334, 17616119, 18315140, 18405882, 18450624, 18470676, 19050454, 19319281, 20324918, 20491919, 23417167, 23691166, 24821305; REF 89-6071.06; Lot Numbers: 17917966, 17935566, 17973925, 17973933, 18000279, 18029371, 18075300, 18217443, 18274229, 18283918, 18283926, 18341444, 18355408, 18419432, 18450472, 18657369, 19017603, 19413374, 19590581, 19751533, 20006282, 20672736, 20883648, 21109582, 21643021, 22014121, 22215563, 22315960, 22727999, 22780722, 23612835, 24153992, 24337610, 24572986, 24773753; REF 89-6169.02; Lot Numbers: 17867882, 17878813, 17878821, 18146171, 18175896, 18231325, 18334720, 18349868, 18349876, 18407010, 18471695, 18534730, 18691621, 18709991, 18859868, 18931751, 19320830, 19674540, 19800770, 19878593, 20125572, 20206161, 20517832, 20674387, 21183619, 21337340, 21813588, 22015174, 22503725, 23225253, 23418549, 23872506, 24155031, 24288678, 24518470, 24573655, 24745550, 24853649, 24897588; REF 89-6219.01; Lot Numbers: 17879058, 17879066, 17930255, 17987868, 18079255, 18136037, 18176047, 18268574, 18319351, 18334789, 18534781, 18572859, 18587858, 18638070, 18658441, 19019713, 19100837, 19415564, 19674611, 19810636, 20174403, 20493455, 20756681, 21053654, 21337358, 21529624, 21813668, 22015300, 22261711, 22729185, 22849398, 23225510, 23418696, 23692433, 24070521, 24070521, 24229627, 24573719, 24774203; REF 89-6225.03; Lot Numbers: 18176063, 18384591, 18633084, 18676957, 18710115, 19019772, 19051182, 19415610, 20007533, 20240554, 20756690, 21053697, 21529659, 21838347, 22378338, 22729231, 23872750, 24229651, 24573751; REF 89-6256.04; Lot Numbers: 17388857, 17884771, 17932023, 17990160, 18180185, 18271036, 18476613, 18537391, 18866777, 18866793, 18979544, 19027131, 19037276, 19052821, 19121232, 19188867, 19188875, 19215351, 19250430, 19328401, 19544841, 19544850, 19685089, 20132473, 20179028, 20894144, 20957424, 21112853, 21559621, 22124661, 22318597, 22589400, 22736465, 22923359, 23341457, 23621918, 24009827, 24294541; REF 89-6257.05; Lot Numbers: 17932015, 17990151, 18081873, 18137662, 18180177, 18271028, 18337162, 18350851, 18476605, 19037233, 19037241, 19103181, 19423450, 19544833, 19812156, 20132457, 20179001, 20179010, 20326809, 20379433, 20500846, 20540194, 20682539, 20801892, 21112845, 21320556, 21423141, 21458029, 21535899, 21698057, 22059847, 22110665, 22188163, 22264314, 22436913, 22589397, 22923341, 23002957, 23426012, 23535219, 23621897, 23699117, 23879142, 24009801, 24009819, 24019267, 24161546, 24311567, 24750009, 24899671; REF 89-6262.06; Lot Numbers: 17884594, 17990080, 18146817, 18215501, 18337138, 18350834, 18350842, 18410690, 18476550, 18476568, 18497238, 18537341, 18591224, 18633981, 18866726, 19027086, 19027094, 19103157, 19423361, 19481730, 19520524, 19685038, 20013546, 20178957, 20326796, 20430841, 20500791, 20894064, 20894072, 21006022, 21186289, 21305575, 21340143, 21423125, 21535830, 21652438, 21777290, 21841829, 22020512, 22020521, 22124653, 22736385, 22757451, 22822865, 23031459, 23621803, 24075411, 24233511, 24294496, 24577971, 24749972; REF 89-6406.03; Lot Numbers: 17885255, 17932226, 17990477, 18008713, 18082180, 18180610, 18271360, 18350914, 18476859, 18867438, 19027537, 19052978, 19339469, 19423935, 19456294, 19685433,20040755, 20132852, 20210806, 20410390, 20683128, 20894689, 21305701, 21652930, 21817941, 22020854, 22124813, 22318757, 22736967, 22783270, 22923682, 23235937, 23260833, 23342054, 23342054, 23426653, 23622419, 24010262, 24010262, 24075939, 24294867, 24294875, 24578296, 24631042, 24631042, 24650956, 24750295; REF 89-6727.02; Lot Number: 19956248, 20211551, 20327318, 20502673, 21585749, 21777417, 21794655, 22383022, 22924280, 23236526, 23880899, 24295544; REF 89-6564.01; Lot Numbers: 18054365, 18533294, 18585967, 18656964, 18808462, 18856165, 19016192, 19514351, 19671912, 19727541, 19876598, 20004148, 20172627, 20305071, 20490836, 20882160, 21336777, 21641659, 22315652, 22376834, 22434037, 22543639, 22780466, 22917590, 23092930, 23527340, 24286761, 24598211, 25021588; REF 89-6588.01; Lot Number 19036601; REF 89-6598.01; Lot Number 18949366; REF 89-6600.01; Lot Number 19036644; REF 89-6725.01; Lot Numbers: 19956264, 20041176, 20241098, 20502681, 21842590, 22021486, 22060506, 22590401, 22737855, 22924298, 23342978, 24162741, 24295552, 24435421, 24578771, 24827854; REF 89-6797.01; Lot Numbers: 21641392, 22055248, 22375508, 22912941, 23217721, 24064455, 24534082, 24741823; REF 89-6826.01; Lot Numbers: 21412207, 21421015, 21811769, 21836659, 22122463, 22868450, 22912932, 23217712, 23523488, 23864531, 24284642, 24570690; REF 89-6858.01; Lot Numbers: 22431477, 22483496, 22868484; REF 89-6990.01; Lot Numbers: 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432, 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432; REF 89-7063.01; Lot Numbers: 22501341, 22719366, 22914065, 23065595, 23328922, 23524739, 23772231, 23866430, 24150142, 24285362; REF 89-7257.01; Lot Numbers: 22392341, 22653715, 22838875, 22957090, 23411451, 23524448, 23607454, 24065491; REF 89-7361.0206; Lot Numbers: 22543428, 22721992, 22869111, 22959458, 23091591, 23525900, 24660556, 24820345, REF 89-7367.01; Lot Numbers: 22502159, 22914911, 23608967, 23867555, 24150871, 24253299; REF 89-7395.04; Lot Numbers: 22801010, 22822929, 23031934, 23236690, 23308569, 23390523, 23623542, 23785251, 24295659, 24855564; REF 89-7429.01; Lot Numbers: 22563146, 22581256, 22723197, 22916095, 23065843, 23220680, 23689082, 24067621, 24286226, 24743482; REF 89-7502.01; Lot Numbers: 22543487, 22635015, 22722303, 22915738, 23027927, 23525993, 23868478; REF: 89-7655.01; Lot Numbers: 24828152, 24833701; REF 94-0268.07: Lot Numbers: 17723310, 17913535, 18269833, 18319757, 18473720, 18862733, 19131721, 19418802, 19480497, 19811225, 19828570, 20409073, 20496744, 20677991, 20889353, 21184742, 21318122, 21338553, 21350683, 21839930, 21923091, 22058238, 22262757, 22317279, 22585986, 22637926, 22732245, 22800130, 23232138, 23531808, 23695343, 23948591, 24006562, 24157635, 24430662, 24575360, 24662586, 24823079; REF 94-0270.06: Lot Numbers: 17152001, 17348329, 18184282, 18621201, 19326692, 19683868, 19715891, 19829222, 19829231, 20539724, 20680971, 20724575, 21350860, 21412661, 21422843, 21697951, 22347304, 22394995, 22436366, 22964353, 23234467, 23424332, 23533942, 24160244, 24243883, 24433177;  REF 47-621.08: Lot Number 15408121; REF 50-12772.13: Lot Numbers: 17901315, 18029178, 18074729, 18181364, 18217208, 18283715, 18632946, 18780113, 18908658, 19068312, 19140185, 19248487, 19414457, 19496165, 19673820, 19900041, 20124895, 20492671, 20492680, 20580701, 20627290, 20801737, 20835611, 20884456, 20932850, 20978604, 21109890, 21643881, 22412647, 22412655, 22636368, 22728633, 22821643, 22849355, 23224293, 23333810, 23691861, 24003450, 24070046, 24229299, 24427527, 24427535, 24573381, 24745218, 24853526, 24923061, 25023153; REF 50-10479.10: Lot Number: 17680313, 18214349, 18734441, 18860439, 19541683, 19675198

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Kits and Trays containing lubricant: || GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B;, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'S¿MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C; GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In

Lot Number 32794811

Ophthalmic Devices

2

No

Nationwide Distribution

DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA || cleaning of fluids from surgical site in or near the eye

Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

General and Plastic Surgery Devices

2

No

US Distribution to: NY

Custom sterile surgical packs labeled as follows: || GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO || Use: Shoulder Arthroscopy

(a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122

General and Plastic Surgery Devices

2

No

Distributed to states of: CA and MO.

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical

Lot Number 15125173

Cardiovascular Devices

2

No

Nationwide Distribution to MD, NY, and IL

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

Lot Numbers: 27273826, 27324507, 27388691, 27453704, 27567701, 27760202, 27784829, 27883843, 27883851, 27915382, 27970710, 28013209, 28103933, 28117702, 28158889, 28158897, 28373571, 28506329, 28550670, 28678471, 28736415, 28793591, 28854235, 28908619, 28929145, 29015901, 29083680, 29169619, 29206205, 29271816, 29468459, 29522443, 29577604, 29631367, 29694350, 29754130, 29799557, 29850826, 29914025, 29914130, 29963231, 30021654, 30092364, 30092612, 30134245, 30143441, 30253965, 30312507, 30385597, 30487930, 30538274, 30608228, 30608236, 30618098, 30728570, 30776441,  30819771, 30906532, 30957381, 30990041, 31074854, 31155540, 31202772, 31338426, 31469590, 31469717, 31576230, 31671966, 31726138, 31776514, 31776549, 31780847, 31835027, 31886529, 31938886, 31939011, 31990297, 32050811, 32128560, 32133377, 32247761, 32247796, 32302978, 32315875, 32355800, 32421037, 32484206, 32544336, 32550891, 32605910, 32689586, 32764742, 32817154, 32869069, 32933761, 33011857, 33087405, 33217089, 33293188, 33357866, 33425822, 33482579, 33482595, 33539361, 33609787, 33682221, 33736436, 33807644, 33807759, 33876287, 34373462, 34450051,  34518799, 34574037, 34624356, 4699631, 34762927, 34826581, 34856368, 34913078, 34963833, 35033777, 35097560, 35170675, 35230658, 35270297, 35327370, 35400670, 35470555, 35523231, 35544500, 35598559, 35636885, 35638881, 35737011, 35774701, 35798614, 35850620, 35862954, 35877929, 36081869, 36107299, 36142123, 36200119, 36273810, 36282581, 36283559, 36341325, 36399631, 36465555, 36465627, 36548211, 36746488, 36823826, 36888726, 37017295, 37079744, 37155364, 37215937, 37269038, 37269142, 37297899, 37462031, 37513707, 37808046, 37869551, 37931204, 37976189,  38032593, 38088239, 38144000, 38180553, 38235294, 38236166, 38270188, 38270807, 38329400, 38392994, 38393399, 38457217, 38457250, 38573891, 38676461, 38688584, 38688648, 38734991, 38823441, 38898602, 39013335, 39063738, 39076660, 39201803, 39260598, 39303623, 39303631, 39353436, 39413822, 39502403, 39515394, 39559549, 39661519, 39706238, 39762395, 39812313, 39877694, 40272115, 40453207, 40522604, 40754595, 40754608, 40887005, 40888462, 41039809, 41080140, 41080166, 41161581, 41213150, 41279829, 41322330, 41356978, 41411210, 41467459, 41470068, 41544872,  41544901, 41601099, 41669982, 41713883, 41762247, 41830537, 41891081, 41980754, 42026874, 42078789, 42175386, 42240731, 42324142, 42345980, 42346077, 42367054, 42367062, 42368698, 42383628, 42467477, 42561121, 42561156, 42642790, 42679146, 43045591, 43091889, 43127731, 43166001, 43217189, 43454011, 43487584, 43501391, 43542580, 43588166, 43641406, 43742899, 43789030, 43824510, 43875309, 43916895, 43953506, 44039767

General and Plastic Surgery Devices

2

No

MS & LA

SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

Lot Numbers: 27453624, 28013145, 28103757, 28117631, 28158774, 28215628, 28230174, 28252349, 28299104, 28317940, 28326230, 28405309, 28455138, 28486735, 28506265, 28568132, 28609969, 28631875, 28736343, 28793541, 28854180, 28908555 28961727, 29015839, 29083612, 29169512, 29214272, 29271744, 29339294, 29412771, 29522363, 29722357, 29754033, 29799485, 29850754, 30021523, 30092305, 30092604, 30134253, 30179216, 30728465, 30819738, 30957330, 31010691, 31015441, 31103782, 31296166, 31402993, 31469522, 31469709, 31576221, 31601554, 31671907, 32333862, 32335500, 32355746,  32550841, 32618796, 32689527, 32728688, 32764718, 32817091, 32834780, 32869000, 32933711, 32980699, 33011814, 33064334, 33087341, 33087350, 33197866, 33682175, 33736364, 33737623, 33783267, 34405461, 34699585, 34762863, 34768309, 34913043, 34939286, 34963841, 35170632, 35270238, 35270529, 35327337, 35544446, 35554708, 35580025, 35598516, 35710820, 35798577, 35828254, 35828449, 35870920, 35898261, 35952677, 36024274, 36081851, 36142094, 36142174, 36200101, 36273801, 36283541, 36309333 36341317, 36530441, 36605837, 36679545, 36953532, 37017210, 37079672,  37079787, 37083356, 37155305, 37189791, 37268916, 37331858, 37395771, 37396029, 37513643, 37654374, 38032551, 38088191, 38180246, 38235278, 38392951, 38457153, 38525030, 38551001, 38623300, 38625866, 38747370, 38788673, 38832507, 38832603, 38997758, 39013351, 39054022, 39076627, 39148951, 39579507, 39661447, 39706174, 39762352, 39812284, 39868780, 40017667, 40080121, 40149328, 40152447, 40264393, 40321968, 40322021, 40342363, 40380888, 40453186, 40453338, 40541549, 40607430, 40890010, 41161601, 41257048, 41263018, 41356935, 41411287, 41467416, 41544848,  41561980, 41601056, 41665404, 41740013, 41755485, 41755506, 42077436, 42077461, 42200721, 42332644, 42332661, 42406164, 42523723, 42523782, 42550246, 43479550, 43493941, 43531688, 43710715

General and Plastic Surgery Devices

2

No

MS & LA

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

General and Plastic Surgery Devices

2

No

SC, FL, OH, NJ, OK, MN, AR

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: || TOTAL JOINT PACK A&B;, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03

REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071

General and Plastic Surgery Devices

2

No

SC, FL, OH, NJ, OK, MN, AR

DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: || TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; || KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; || TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; || PACEMAKER PACK, REF 89-8381.01;