Maquet recalls specific large patient TBG P tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000044415, 3000046393, or 3000046736.
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 large patient TBG P tubing sets that could fail sterility during sterilization. This risk occurs because the tubing's design might block humidity and gas flow, potentially leading to contamination.
The tubing's closed stopcock and non-vented cap design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, increasing the risk of contamination.
Healthcare professionals using the Maquet Getinge-BEQ-T 9405 Large Patient TBG P tubing sets for extracorporeal circulation. Patients receiving treatments with these sets are at risk if the tubing becomes contaminated.
Check for the model 'Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P' with batch numbers 3000044415, 3000046393, or 3000046736. The product is sold by Maquet Cardiovascular, LLC.
Verify the batch numbers on the tubing set: 3000044415, 3000046393, or 3000046736.
The closed stopcock and non-vented cap design may prevent proper humidity and gas flow during sterilization, risking contamination.
Batch numbers 3000044415, 3000046393, and 3000046736.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1578-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1578-2019 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.
