Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 21 of 63
Zimmer Biomet, Inc.
Class II Terminated
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Reason: Lack of an adequate sterilization validation.
Z-1960-2019 July 24, 2019 Warsaw, IN
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1601-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1662-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1573-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1613-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1558-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1580-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1554-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1642-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1578-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1593-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1631-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1537-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1617-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1678-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1557-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1664-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1500-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1562-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1561-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1528-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1671-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1603-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1640-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas i...
Z-1515-2019 June 5, 2019 Wayne, NJ