medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 7010

Recalled Product

Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504

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

Distribution: Nationwide (United States)
Lot/Code Info: Batch Numbers: 3000044419 3000045727 3000065141
View official government recall

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