Maquet recalls pediatric ECC devices with batch numbers 3000058044, 3000062463, and 3000075430 due to potential sterility issues during sterilization.
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 devices that may not maintain sterility during sterilization. This could lead to infections if the device is used without proper sterility.
During sterilization, the device's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections.
Parents and healthcare providers using pediatric extracorporeal circulation devices with specific batch numbers. Children receiving such treatments are at risk if the device fails to maintain sterility.
Check the batch numbers on the device: 3000058044, 3000062463, or 3000075430. The product is a pediatric extracorporeal circulation device from Maquet Getinge-BEQ-TOP 31000.
Look for batch numbers 3000058044, 3000062463, or 3000075430 on the device.
Batch numbers 3000058044, 3000062463, and 3000075430.
The device's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing during sterilization, risking sterility.
Check the batch numbers; if affected, contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1523-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1523-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
