medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701

Recalled Product

Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992

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: 3000043679 3000047252 3000050833 3000053134 3000054956 3000056048 3000060481 3000063710 3000067185 3000071400 3000073429 3000075387 3000075899
View official government recall

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