BEUDAMED
    FDA Enforcement Class I Terminated

    Puritan Bennett 980 Series Ventilator, 980X1ENNISB

    Recall: Z-0348-2022 · Reported December 15, 2021

    Enforcement

    Recall Number
    Z-0348-2022
    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, 980X1ENNISB

    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 - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    278 total