Maquet recalls Childrens Large ECC Packs with batch 3000059724 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 Childrens Large ECC Packs (batch 3000059724) because improper sterilization could lead to contamination. This affects medical devices used in extracorporeal circulation.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device after use.
Healthcare providers using these packs for pediatric extracorporeal circulation are most at risk. The affected units are specifically batch 3000059724.
Check for the batch number 3000059724 on the Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack. The product is sold under the brand Maquet.
Look for batch number 3000059724 on the product label.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
Check the batch number; if it's 3000059724, contact Maquet for guidance.
The recall indicates potential sterility issues, so it should not be used until the batch number is verified.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1665-2019 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.
