Maquet recalls specific ECC QUADROX iD 3/8 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 ECC QUADROX iD 3/8 tubing sets because their design might not allow proper humidity and gas flow during sterilization. This could lead to contamination of medical devices, making them unsafe for use.
The tubing's closed stopcock and non-vented cap 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 medical device.
Healthcare professionals using the recalled tubing sets for extracorporeal circulation (ECC) procedures. Patients receiving these devices are at risk of contamination if the tubing is not properly sterilized.
Check for the model 'Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8' with material code 701049440R02. The batch number is 3000076147.
Identify the model number and batch number to confirm if your tubing set is recalled.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination of the medical device.
The batch number is 3000076147.
If the tubing is not properly sterilized due to the design issue, it could lead to contamination, posing a risk to patients.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1633-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1633-2019 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.
