Z-0338-2022 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, 980A1ENNISB
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 - 10884521201897 Serial Numbers: 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508 & 35B1701569.