Maquet recalls specific ECC Quadrox iD models due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers starting with 3000079889.
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 ECC Quadrox iD models because their stopcock design may not allow proper humidity and gas flow during sterilization. This could lead to contamination of medical devices, posing a risk to patient safety.
The closed stopcock configuration in these devices may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of medical devices.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD models for extracorporeal circulation. Patients receiving treatments with these devices are at risk if the sterilization process fails.
Check for the model name 'Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8"' and batch numbers starting with 3000079889. The product has a specific material code: 701050060R01.
Identify the model name and batch number to confirm if your device is affected.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination of medical devices.
Batch numbers starting with 3000079889.
Look for the model name 'Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8"' and batch numbers starting with 3000079889.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1634-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1634-2019 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.
