Maquet recalls neonatal ECC tubing packs with batch numbers 3000051158, 3000061507, 3000067518, 3000069468 due to potential sterility issues during sterilization.
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 neonatal extracorporeal circulation tubing packs that may not maintain sterility after sterilization. This could lead to infections in newborns if the tubing is used without proper sterility.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could result in contaminated tubing that introduces infection risks during neonatal ECMO procedures.
Newborns receiving extracorporeal circulation (ECMO) treatment using the recalled tubing packs are most at risk. Healthcare providers using these specific packs for neonatal ECMO are affected.
Check for batch numbers 3000051158, 3000061507, 3000067518, or 3000069468 on the tubing pack. The product is labeled as Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal with material code 709000069R02.
Verify the batch numbers on the tubing pack: 3000051158, 3000061507, 3000067518, or 3000069468.
The tubing pack may not maintain sterility after sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Check the batch numbers on the pack. If it matches the listed numbers, stop using it and contact Maquet for guidance.
The recall record does not mention a remedy or fix for this specific issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1674-2019 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.
