Maquet recalls ROTAFLOW Drive model 701022161 due to loose ODU plug causing flow fluctuations. Affected units have specific serial numbers and UDI.
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Maquet is recalling a specific ROTAFLOW Drive model because a loose plug can cause flow measurements to fluctuate. This could lead to inaccurate readings during medical procedures.
A loose ODU plug or coaxial cable connection can cause the flow values displayed on the console to fluctuate. This may lead to inaccurate readings during critical medical procedures.
Healthcare professionals using the ROTAFLOW Drive system for medical procedures are most likely affected. The recall targets specific model units with known serial numbers.
Check for the model number 701022161 on the device. Affected units have specific serial numbers listed in the recall notice and a unique UDI code.
Identify the model number on the device, which should be 701022161.
Compare your device's serial number to the list provided in the recall notice.
The recall is for potential flow fluctuations, which could affect medical readings but does not pose a direct safety risk to users.
Check for the model number 701022161 and verify your serial number against the list provided in the recall notice.
The recall does not require immediate action; you can check the model and serial number to confirm if your device 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-0678-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0678-2020 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.
