BEUDAMED
    FDA Enforcement Class I Terminated

    Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

    Recall: Z-0349-2022 · Reported December 15, 2021

    Enforcement

    Recall Number
    Z-0349-2022
    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, 980X1JADIJJ

    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 - 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

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    278 total