Maquet recalls Getinge-BO-TOP 30300 tubing sets with batch numbers 3000043293, 3000045086, 3000050830, 3000058048 due to potential sterility issues during sterilization.
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 specific Getinge-BO-TOP 30300 tubing sets because their design may fail to ensure sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents the system from maintaining proper sterility assurance, increasing infection risk.
Medical professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could face infection if the tubing is not properly sterilized.
Check for batch numbers 3000043293, 3000045086, 3000050830, or 3000058048 on the tubing sets. These are part of the Maquet Getinge-BO-TOP 30300 model.
Look for batch numbers 3000043293, 3000045086, 3000050830, or 3000058048 on the tubing sets.
The tubing's closed stopcock design may prevent proper humidity and gas flow during sterilization, risking infection if not properly sterilized.
Batch numbers 3000043293, 3000045086, 3000050830, and 3000058048.
The recall does not provide a fix; affected users should stop using the tubing sets and contact Maquet for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1522-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1522-2019 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.
