Maquet recalls specific batch numbers of Getinge-BO-TOP 13901 RAPID RESPONSE tubing for potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels.
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 batches of Getinge-BO-TOP 13901 RAPID RESPONSE tubing due to a risk that the sterilization process might not properly ensure sterility. This could lead to infections if the tubing is used in medical procedures.
During sterilization, the tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections if the tubing is used in medical procedures.
Healthcare professionals using the Getinge-BO-TOP 13901 RAPID RESPONSE tubing for extracorporeal circulation in medical procedures are most at risk.
Check for batch numbers: 3000044426, 3000049067, 3000053796, 3000054622, 3000067221, 3000067796, 3000072147, or 3000074175 on the tubing packaging.
Look for batch numbers 3000044426, 3000049067, 3000053796, 3000054622, 3000067221, 3000067796, 3000072147, or 3000074175 on the tubing packaging.
The tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance levels.
Batch numbers 3000044426, 3000049067, 3000053796, 3000054622, 3000067221, 3000067796, 3000072147, and 3000074175.
The recall record does not specify a remedy, so contact Maquet Cardiovascular directly 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-1535-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1535-2019 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.
