Maquet recalls specific Getinge-BEQ-TOP 5208 ECC sets due to potential sterility issues during sterilization. Affected units have batch numbers 3000044413-3000065084. Contact for replacement.
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
Maquet is recalling certain Getinge-BEQ-TOP 5208 ECC sets because their design may fail to ensure sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could result in the equipment not being sterile after sterilization, increasing infection risk.
Healthcare professionals using the Getinge-BEQ-TOP 5208 ECC sets for extracorporeal circulation. Patients using these sets during medical procedures are at risk of infection if the equipment is not properly sterilized.
Check for batch numbers 3000044413, 3000049064, 3000050885, 3000054157, 3000058832, 3000062461, or 3000065084 on the product label.
Look for batch numbers 3000044413 through 3000065084 on the product label.
The recalled product is the Maquet Getinge-BEQ-TOP 5208 ECC Set with material code 701067350.
Check the batch number on the product label; affected units have batch numbers 3000044413, 3000049064, 3000050885, 3000054157, 3000058832, 3000062461, or 3000065084.
The recall does not specify a remedy, so contact Maquet directly for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1585-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1585-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
