medical Class II Updated 2019-06-05

Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Mat

Recalled Product

Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078


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: 3000047631 3000054421 3000063290 3000071804 3000073166 3000075337
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →