Maquet recalls pediatric ECC tubing packs that may not maintain sterility during sterilization due to design flaws. Affected units have specific batch numbers. Consumers should contact Maquet for details.
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 packs that may not stay sterile after sterilization. This could lead to infections if used in medical procedures without proper sterility.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This can compromise the sterility assurance level, increasing infection risk during medical procedures.
Healthcare providers using pediatric extracorporeal circulation (ECC) tubing packs with specific batch numbers. Patients undergoing ECC procedures are at risk if the tubing is not properly sterilized.
Check for batch numbers: 3000047631, 3000054421, 3000063290, 3000071804, 3000073166, or 3000075337. The product is a pediatric ECC tubing pack from Maquet Getinge-BEQ-TOP 50903.
Reach out to Maquet Cardiovascular for specific instructions on handling affected units.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking infection if not properly sterilized.
Batch numbers 3000047631, 3000054421, 3000063290, 3000071804, 3000073166, and 3000075337.
Check the batch number on the packaging; affected units have the specific batch numbers listed above.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1600-2019 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.
