BEUDAMED
    FDA Enforcement Class I Terminated

    Puritan Bennett 980 Series Ventilator, 980A1ENNISB

    Recall: Z-0338-2022 · Reported December 15, 2021

    Enforcement

    Recall Number
    Z-0338-2022
    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, 980A1ENNISB

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

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    278 total