Z-0350-2022 Class I Terminated

Recalled by Covidien Llc — Mansfield, MA

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, 980X1PLDIPC

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 - 10884521171619 Serial Numbers: 35B1700425 35B1700438 35B1700458 35B1700460 35B1700656 35B1700659 35B1700660