Maquet recalls Getinge-BEQ-TOP 15800 tubing packs with batch numbers 3000062267 and 3000065087 due to 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 specific tubing packs used in medical extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used without proper sterility.
During sterilization, the tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the tubing is used without proper sterility.
Healthcare professionals using the Getinge-BEQ-TOP 15800 tubing packs for extracorporeal circulation systems are most at risk. Patients receiving such treatments could be affected if the tubing is not properly sterilized.
Check for batch numbers 3000062267 or 3000065087 on the tubing pack. The product is labeled as Maquet Getinge-BEQ-TOP 15800 Tubing Pack with material code 3000065087.
Look for batch numbers 3000062267 or 3000065087 on the tubing pack.
The tubing pack may not maintain proper sterility assurance levels during sterilization due to its closed stopcock configuration, which can prevent humidity and ethylene oxide gas from flowing into the fluid path.
Batch numbers 3000062267 and 3000065087 are affected.
Check for batch numbers 3000062267 or 3000065087 on the Maquet Getinge-BEQ-TOP 15800 Tubing Pack with material code 3000065087.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1498-2019 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.
