Maquet recalls specific custom tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000048719, 3000062269, 3000074321, 3000077543.
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 custom tubing sets used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used without proper sterility assurance.
During sterilization, the tubing'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 if the tubing is used without proper sterility.
Healthcare professionals using the Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390 in extracorporeal circulation systems are most at risk. Patients receiving treatments through these systems could be affected if the tubing is not properly sterilized.
Check for batch numbers 3000048719, 3000062269, 3000074321, or 3000077543 on the Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390. These units were sold with specific batch numbers listed in the recall.
Look for batch numbers 3000048719, 3000062269, 3000074321, or 3000077543 on the tubing set.
The affected batch numbers are 3000048719, 3000062269, 3000074321, and 3000077543.
The tubing may not maintain sterility during sterilization, potentially leading to infections if used without proper sterility assurance.
The recall does not specify a remedy; affected units should be checked for the listed batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1615-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1615-2019 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.
