Device Recall DeRoyal Surgical Kits and trays

  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    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
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including SD and NE.
  • Descripción del producto
    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
  • Manufacturer