FDA Enforcement
Class I
Terminated
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Recall: Z-0343-2022
·
Reported December 15, 2021
Enforcement
- Recall Number
- Z-0343-2022
- Event ID
- 88987
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Covidien Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 15, 2021
- Initiation Date
- November 4, 2021
- Classification Date
- December 9, 2021
- Termination Date
- July 9, 2024
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Reason
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Code Info
GTIN/UDI - 10884521201415 Serial Numbers: 35B1700408 35B1700412 35B1700499 35B1700525
Distribution
Worldwide distribution - US Nationwide.
Quantity
278 total