Maquet recalls specific Rotaflow Pack models due to potential sterility issues when sterilized. The closed stopcock design may prevent proper humidity and gas flow, risking contamination during sterilization.
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 Rotaflow Packs because their design can cause sterility issues during sterilization. This means the medical device might not be safe for use after sterilization, potentially leading to infections.
The closed stopcock and non-vented cap configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, increasing the risk of contamination.
Healthcare professionals using the specific Rotaflow Pack models listed in the recall. Patients receiving treatments with these packs are at risk if the device is not properly sterilized.
Check for the model number BEQ-T 53500 Evanston Rotaflow Pack with material code 709000215R01. The batch numbers listed are 3000045168, 3000046484, 3000062270, 3000064946, and 3000084054.
Verify the model number and batch numbers listed in the recall notice to confirm if your device is affected.
The closed stopcock and non-vented cap design may prevent proper humidity and gas flow during sterilization, risking contamination.
The recall notice does not specify a remedy, so check the product details to confirm if it's affected and contact the manufacturer for further instructions.
Look for the model BEQ-T 53500 Evanston Rotaflow Pack with material code 709000215R01 and batch numbers 3000045168, 3000046484, 3000062270, 3000064946, or 3000084054.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1677-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1677-2019 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.
