Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 27 of 63
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
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-1656-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
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-1530-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
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-1675-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
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-1616-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
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-1521-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
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-1606-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
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-1532-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
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-1655-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
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-1572-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
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-1551-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
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-1576-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
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-1586-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
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-1538-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
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-1570-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
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-1625-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
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-1517-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
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-1676-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
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-1545-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
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-1652-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874
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-1535-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
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-1627-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
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-1519-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
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-1547-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
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-1539-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
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-1618-2019 June 5, 2019 Wayne, NJ