Maquet recalls pediatric ECC tubing sets that may not maintain sterility after sterilization due to design flaws. Affected units have batch number 3000071198.
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 pediatric extracorporeal circulation tubing sets that may not stay sterile after sterilization. This could lead to infections if the tubing is used without proper sterility.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from reaching the fluid path. This could compromise sterility assurance, potentially causing infections.
Healthcare providers using pediatric extracorporeal circulation equipment are most at risk. The affected units have batch number 3000071198.
Check for batch number 3000071198 on the Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC tubing sets.
Look for batch number 3000071198 on the tubing set.
The tubing's design may prevent proper sterilization, risking infections during medical use.
Check the batch number; if it matches 3000071198, contact Maquet for guidance.
The recall addresses infection risk, not direct injury. The hazard level is low risk.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1561-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1561-2019 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.
