Maquet recalls specific table line tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000066690, 3000072826, or 3000080852.
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 table line tubing sets used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the equipment is used without proper sterility.
Healthcare professionals using the Maquet Getinge-BEQ-T 37305 table line tubing sets for extracorporeal circulation systems. Those with batch numbers 3000066690, 3000072826, or 3000080852 are most at risk.
Check the batch number on the tubing set, which should be one of 3000066690, 3000072826, or 3000080852. The product is labeled as Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE with material code 701067577.
Look for batch numbers 3000066690, 3000072826, or 3000080852 on the tubing set.
The Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE with material code 701067577.
Batch numbers 3000066690, 3000072826, and 3000080852.
During sterilization, the closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path, potentially compromising sterility assurance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1587-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1587-2019 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.
