Maquet recalls neonatal tubing sets that may not maintain sterility during sterilization due to design flaws. Affected units have specific batch numbers and require immediate action to prevent infection risks.
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 tubing sets that could fail to stay sterile during sterilization. This risk might lead to infections in newborns if the tubing isn't properly sterilized.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper sterility assurance, potentially allowing harmful bacteria to grow in the tubing.
Newborns and healthcare providers using the Maquet Getinge-BEQ-TOP 2202 neonatal tubing sets. Those with the specific batch numbers listed are most at risk.
Check for the product name 'Maquet Getinge-BEQ-TOP 2202 Neonatal Special' and batch numbers 3000041407 or 3000069806. The product was sold with these specific batch numbers.
Identify the batch number on the tubing set to confirm if it matches 3000041407 or 3000069806.
The tubing's design may prevent proper sterility during sterilization, risking infections in newborns.
Batch numbers 3000041407 and 3000069806.
The recall does not require immediate stoppage; however, affected units should be checked for the specific batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1550-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1550-2019 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.
