BEUDAMED
    FDA Enforcement Class I Terminated

    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

    Recall: Z-1279-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1279-2022
    Event ID
    90250
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge Usa Sales Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2022
    Initiation Date
    May 2, 2022
    Classification Date
    June 23, 2022
    Termination Date
    August 6, 2024
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035, United States

    Description

    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

    Reason

    Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

    Code Info

    UDI-DI: 07325710010457 Serial Numbers: 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50061, 50062, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132. (Note: UDI was corrected July 7, 2022)

    Distribution

    US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia

    Quantity

    47 units US