Maquet recalls Quadrox iD Pack model 701054389R02 due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels.
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 Quadrox iD Pack material 701054389R02 because sterilization may fail to ensure sterility. This could lead to infections if the device is used without proper sterility.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the device is used without proper sterility.
Healthcare professionals using the Quadrox iD Pack for extracorporeal circulation (ECC) systems are most at risk. Patients receiving such treatments may be exposed to infection if the device is not properly sterilized.
Check for the model number 701054389R02 on the Quadrox iD Pack. Affected units were sold with batch numbers 3000049066 or 3000053533.
Identify the model number 701054389R02 and batch numbers 3000049066 or 3000053533 on the Quadrox iD Pack.
The recall is due to potential sterility issues during sterilization. The closed stopcock configuration may prevent proper humidity and gas flow, compromising sterility assurance levels.
Check the model number and batch numbers on the product. If it matches 701054389R02 with batch numbers 3000049066 or 3000053533, contact Maquet for further instructions.
Yes, if the device is used without proper sterility assurance, it could lead to infections during extracorporeal circulation procedures.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1648-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1648-2019 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.
