medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For

Recalled Product

Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01


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: 3000080724 3000084928
View official government recall

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