Z-0349-2022 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, 980X1JADIJJ
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 - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026