Maquet recalls Getinge-BEQ-TOP 3700 tubing packs with batch 3000069367 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 for extracorporeal circulation use because they might not stay sterile after sterilization. This could lead to infections if the tubing isn't properly sterilized.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could allow contaminants to remain in the tubing after processing.
Healthcare professionals using the tubing for extracorporeal circulation (ECC) procedures are most at risk. The affected units have batch number 3000069367.
Check for batch number 3000069367 on the tubing pack. The product is labeled as Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material 701049510.
Look for batch number 3000069367 on the tubing pack label.
The tubing may not stay sterile after sterilization due to its closed stopcock design during processing.
The official recall notice does not specify a remedy or action for affected units.
The recall indicates a potential sterility risk, so it should not be used until the manufacturer confirms a fix.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1504-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1504-2019 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.
