Covidien recalls Puritan Bennett 980 Series ventilators with manufacturing error causing potential inoperability. Affected units have specific serial numbers and GTIN.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Covidien is recalling Puritan Bennett 980 Series ventilators due to a manufacturing error that might make them stop working during use. This could affect patients relying on these life-support devices.
A capacitor assembly error in the ventilator may cause it to stop working during use. This could lead to life support failure for patients dependent on the device.
Healthcare facilities using the affected ventilators are most at risk. Patients on life support with these devices could be impacted if the ventilator becomes inoperable.
Check for serial numbers starting with 35B1703376 on the ventilator. The GTIN/UDI is 10884521171787. These units were sold with the specific model designation 980X1ENAIQC.
Verify if the ventilator is functioning properly as the error may cause it to become inoperable during use.
Check if your ventilator has serial number 35B1703376 or GTIN/UDI 10884521171787 to see if it's affected.
The recall is for potential inoperability due to a manufacturing error; contact your healthcare provider for guidance.
Look for the serial number starting with 35B1703376 or the GTIN/UDI 10884521171787 on the device.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0345-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0345-2022 from Covidien. 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.
