Maquet recalls small patient 1/4 tubing sets due to potential sterility issues when sterilized. 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 small patient 1/4 tubing sets that could become contaminated during sterilization. This affects hospitals and medical facilities using these devices for extracorporeal circulation.
The tubing's closed stopcock design may prevent humidity and ethylene oxide gas from flowing properly during sterilization. This could lead to contamination of the tubing, compromising the sterility assurance level for patient safety.
Hospitals and medical facilities using the Maquet Getinge-BO-TOP 20705 Small Patient 1/4 tubing sets for extracorporeal circulation are most at risk. Patients receiving such treatments could be affected if the tubing becomes contaminated.
Check for the model 'Getinge-BO-TOP 20705 Small Patient 1/4' with material code 701053486R01. Batch numbers 3000080434 or 3000081004 are also associated with this recall.
Identify the model number and batch numbers to confirm if your tubing set is affected.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000080434 and 3000081004 are affected.
Look for the model 'Getinge-BO-TOP 20705 Small Patient 1/4' with material code 701053486R01 and 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-1644-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1644-2019 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.
