Z-0340-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 15, 2021
- Initiation Date
- November 4, 2021
- Termination Date
- July 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278 total
Product Description
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Reason for Recall
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
GTIN/UDI - 10884521171114 Serial Numbers: 35B1700409 35B1700443 35B1700457 35B1700462 35B1700473 35B1700476 35B1700483 35B1700487 35B1700490 35B1700511 35B1700552 35B1700567 35B1700569 35B1700570