Maquet recalls specific BEQ-T 9411 Lurie Children's 1/4 ADAPT tubing sets due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000076765.
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 certain BEQ-T 9411 Lurie Children's 1/4 ADAPT tubing sets because a design flaw may prevent proper sterilization, risking infection during medical procedures. This affects specific batch numbers and is critical for hospitals using these devices.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections in patients.
Hospitals and medical facilities that use the recalled tubing sets for pediatric extracorporeal circulation procedures. Patients undergoing such treatments are at risk if the tubing is not properly sterilized.
Check for the model 'BEQ-T 9411 Lurie Children's 1/4 ADAPT' with batch numbers starting with 3000076765. The product is sold under Maquet Getinge.
Look for batch numbers starting with 3000076765 on the tubing set.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking infection in patients.
The recall record does not specify a remedy, so hospitals should contact Maquet for guidance.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the manufacturer provides a solution.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1679-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1679-2019 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.
