FDAFDA · Food and drugs·Recall number Z-0342-2022
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Published December 15, 2021 · Recall initiated: November 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien Llc
- Distributor
- Worldwide distribution - US Nationwide.
- Lot
- GTIN/UDI - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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