Maquet recalls Getinge-BO-TOP 15200 tubing sets due to potential sterility issues during sterilization. Affected units have specific batch numbers and material codes.
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-BO-TOP 15200 tubing sets because they may not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used in medical procedures without being fully sterile.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could be affected if the tubing is not properly sterilized.
Check for the material code 701050647R01 and batch numbers 3000045166, 3000050578, or 3000054620 on the packaging.
Look for the material code 701050647R01 and batch numbers 3000045166, 3000050578, or 3000054620 on the packaging.
The tubing's closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000045166, 3000050578, and 3000054620 are affected.
Check for the material code 701050647R01 and the listed batch numbers on the packaging.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1638-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1638-2019 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.
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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.
