PlainRecalls
FDA Devices Critical Class I Terminated

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Reported: December 15, 2021 Initiated: November 4, 2021 #Z-0348-2022

Product Description

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

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.

Details

Recalling Firm
Covidien Llc
Units Affected
278 total
Distribution
Worldwide distribution - US Nationwide.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
Puritan Bennett 980 Series Ventilator, 980X1ENNISB. Recalled by Covidien Llc. Units affected: 278 total.
Why was this product recalled?
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 15, 2021. Severity: Critical. Recall number: Z-0348-2022.