Maquet recalls specific ECC QUADROX ID 3 models due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels if humidity and ethylene oxide gas cannot flow properly.
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 3 models because their tubing design may prevent proper humidity and gas flow during sterilization, risking contamination. This could lead to infections if the equipment is used without proper sterility.
The closed stopcock design may block 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 the equipment and infection risks.
Medical professionals using the Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 models for extracorporeal circulation. Those in hospitals or clinical settings with these specific models are most at risk.
Check for the model number 'Getinge-BEQ-TOP 22600 ECC QUADROX ID 3' and batch numbers 3000053103, 3000066198, 3000071830, or 3000073677 on the product.
Identify the model number and batch numbers listed in the recall notice to confirm if your unit is affected.
The affected models are Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 with batch numbers 3000053103, 3000066198, 3000071830, or 3000073677.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and infection.
The recall notice does not specify a remedy or action steps beyond checking product details to confirm if your unit is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1632-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1632-2019 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.
