Maquet recalls Getinge-BEQ-TOP 37500 ECC QUADROX ID (material 701055601) due to potential sterility issues during sterilization. Affected units have specific batch numbers.
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 a specific model of cardiovascular tubing for extracorporeal circulation. The issue could lead to unassured sterility during sterilization, which is critical for medical safety.
During sterilization, the tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections.
Healthcare professionals using the Getinge-BEQ-TOP 37500 ECC QUADROX ID tubing for extracorporeal circulation systems. Patients undergoing such procedures are at risk if the tubing is not properly sterilized.
Check for the model name 'Getinge-BEQ-TOP 37500 ECC QUADROX ID' and material code 701055601. Affected units have batch numbers 3000048238, 3000061109, or 3000069075.
Identify the model name and material code to confirm if your unit is affected.
The recalled model is Getinge-BEQ-TOP 37500 ECC QUADROX ID with material code 701055601.
Batch numbers 3000048238, 3000061109, and 3000069075 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1540-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1540-2019 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.
