medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adul

Recalled Product

Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack

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: (1)3000058184, 3000067382, 3000069380, 3000071967, 3000074322 (2)3000077734
View official government recall

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