medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿

Recalled Product

Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in 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) 3000050886 (2) 3000066508, 3000081906
View official government recall

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