Maquet recalls neonatal ECC QPiD tubing with batch numbers 3000046120, 3000062048, 3000068120 due to potential sterility failure during sterilization. Affected units may not meet sterility standards if improperly sterilized.
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 that could fail sterility during sterilization. This poses a risk of infection if the tubing is not properly sterilized.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the tubing is not sterilized correctly.
Healthcare providers using neonatal extracorporeal circulation equipment are most at risk. The specific tubing models and batch numbers are listed in the recall notice.
Check for batch numbers 3000046120, 3000062048, or 3000068120 on the tubing. The product is labeled as Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD with material code 701051935R01.
Look for batch numbers 3000046120, 3000062048, or 3000068120 on the tubing.
The tubing's design may prevent proper sterilization, risking infection if not handled correctly.
Check the batch numbers listed in the recall notice. If you have one of the affected batch numbers, contact Maquet for guidance.
The recall indicates a potential sterility risk during sterilization, so affected units should be checked and handled according to the recall instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1641-2019 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.
