Maquet recalls specific Getinge-BEQ-TOP 25003 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 Getinge-BEQ-TOP 25003 tubing sets because their design may cause sterility problems during sterilization. This could lead to contaminated medical equipment if not properly sterilized.
The tubing's closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) systems are most at risk. Patients receiving ECC treatments may be affected if the tubing is not properly sterilized.
Check for the model number 3/8X3/8 TO 7LPM and material code 701063255 on the tubing. Affected units have batch numbers: 3000041007, 3000044052, 3000045730, 3000047318, 3000054334, 3000054615, or 3000063091.
Identify the model number 3/8X3/8 TO 7LPM and material code 701063255 on the tubing.
The closed stopcock and non-vented cap design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000041007, 3000044052, 3000045730, 3000047318, 3000054334, 3000054615, and 3000063091 are affected.
Look for the model number 3/8X3/8 TO 7LPM and material code 701063255 with 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-1554-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1554-2019 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.
