Lot Number 22622679

General Hospital and Personal Use Devices

2

No

Nationwide

NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 || Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.

Lot numbers: 08150012, 08156012, 08179012, 08172012, 08221012, 08207012, 08247012, 08249012, 08302012, 08270012, 08310012, 08312012, 08354012, 09022012, and 08354012

General and Plastic Surgery Devices

2

No

LA & MS

DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

Lot numbers: 08150012, 08156012, 08172012, 08192012, 08221012, 08247012, 08249012, 08302012, 08270012, 08312012, 08354012, 09022012, and 08354012

General and Plastic Surgery Devices

2

No

LA & MS

DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

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)

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 364817213

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, || general hospital

1) DeRoyal(R), REF 71-6510, Lot 36408631  2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

Suction canisters labels as follows: || 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. || 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only || general hospital

Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

General and Plastic Surgery Devices

2

No

Distributed in the states of MI, GA, OH, IL, MO, and IN.

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363

General and Plastic Surgery Devices

2

No

Distributed in the states of MI, GA, OH, IL, MO, and IN.

DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

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

lot numbers 33347799, 33444071, and 33423747

Obstetrical and Gynecological Devices

2

No

US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

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.

Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366

General and Plastic Surgery Devices

2

No

USA Nationwide Distribution in the state of PA

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE || Product Usage: general surgical

GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694   GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740

General and Plastic Surgery Devices

2

No

Nationwide Distribution including SD and NE.

Custom surgical kits and trays: || GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 || GEO-MED TOTAL HIP PACK, REF 89-6664.03 || surgical kits

Lot Numbers: 17486924, 17920399, 18040342, 18316290, 18551118, 19341884, 19396771, 19464008, 19504031,  19546960, 19743023, 20687057, 21157488, 21413621, 21699341, 22142544, 22373051, 22688811,  23111424, 23161430, 23434063, 23794510, 24095551, 24163955, 24296281, 24451957, 24508634,  24793826, 25043550, 25313548, 25439757, 25747451, 26023059, 26199281, 26544541, 26611133, 26706327, 26943568, 27105291, 27304418, 27571604

Hematology and Pathology Devices

2

No

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

DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood

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

Lot Numbers: 23383104, 24246953, 24328238, 24557401, 24797341, 24947178, 25112885, 25139279, 25373479, 25601267, 25831994, 26197358, 26634706, 26874806, 27121161, 27228507, 27467209

Hematology and Pathology Devices

2

No

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

DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood

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

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

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 Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32871821, 32976471, 33105247

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911

Physical Medicine Devices

2

No

Nationwide Distribution.

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. || Physical Therapy.