Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 23 of 63
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01
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-1637-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
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-1526-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
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-1641-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
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-1571-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473
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-1549-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883
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-1582-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
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-1536-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
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-1524-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
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-1542-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01
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-1636-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
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-1667-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395
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-1592-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
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-1559-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
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-1646-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
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-1612-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
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-1597-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
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-1639-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
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-1574-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213
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-1607-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01
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-1643-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
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-1650-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
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-1605-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168
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-1591-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in 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-1653-2019 June 5, 2019 Wayne, NJ
Maquet Cardiovascular, LLC
Class II Terminated
Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01
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-1657-2019 June 5, 2019 Wayne, NJ