BEUDAMED
    FDA Enforcement Class II Ongoing

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    Recall: Z-1775-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1775-2022
    Event ID
    90766
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2022
    Initiation Date
    August 19, 2022
    Classification Date
    September 22, 2022
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    Reason

    Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

    Code Info

    UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340

    Distribution

    Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.

    Quantity

    5 US