Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD
Recalled Product
Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
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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