Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 26 of 63
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
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-1543-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
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-1632-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
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-1587-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
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-1498-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
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-1548-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
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-1670-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280
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-1609-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
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-1511-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
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-1660-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
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-1567-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
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-1674-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
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-1635-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
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-1555-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
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-1658-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
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-1668-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
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-1663-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
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-1520-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
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-1648-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
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-1531-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
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-1621-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
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-1626-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
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-1600-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
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-1628-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
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-1513-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
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-1540-2019 June 5, 2019 Wayne, NJ