Maquet recalls Getinge-BEQ-TOP 25001 MONTEFIORE tubing sets due to potential sterility issues during sterilization. Affected units have batch numbers 3000054551 or 3000065085.
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 specific Getinge-BEQ-TOP 25001 MONTEFIORE tubing sets because their design may fail to ensure sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
The tubing sets' closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, increasing infection risk.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) systems are most at risk. The affected units have specific batch numbers.
Check for batch numbers 3000054551 or 3000065085 on the tubing sets. The product name is Getinge-BEQ-TOP 25001 MONTEFIORE with material code 701053906.
Look for batch numbers 3000054551 or 3000065085 on the tubing sets.
The tubing sets' design may prevent proper humidity and ethylene oxide gas flow during sterilization, potentially compromising sterility assurance.
Batch numbers 3000054551 and 3000065085.
Check for batch numbers 3000054551 or 3000065085 on the Getinge-BEQ-TOP 25001 MONTEFIORE tubing sets with material code 701053906.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1530-2019 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.
