Maquet Cardiovascular, LLC recalls Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material
Recalled Product
Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
Hazard / Issue
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
Issued by
FDA
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