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Maquet Cardiovascular Recalls
252 recalls on record · January 16, 2013 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 30300 Material:701052623
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 15705 Material: 701051122
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 4901 Material: 701050839
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 22701 Material: 701050790
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T-22800 Material: 701049506
Hazard: 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 into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured