Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 24 of 63
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 15705 Material: 701051122
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-1514-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
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-1638-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
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-1669-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
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-1602-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
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-1568-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
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-1649-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444
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-1622-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
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-1644-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266
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-1608-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
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-1584-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515
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-1516-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
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-1590-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966
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-1512-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
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-1673-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
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-1629-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
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-1523-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
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-1645-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837
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-1589-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
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-1527-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
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-1659-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
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-1575-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
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-1564-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
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-1615-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
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-1604-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
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-1533-2019 June 5, 2019 Wayne, NJ