BEUDAMED
    FDA Enforcement Class II Ongoing

    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

    Recall: Z-1256-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1256-2023
    Event ID
    91716
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 15, 2023
    Address
    3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States

    Description

    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

    Reason

    Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

    Code Info

    GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664

    Distribution

    US Nationwide distribution in the states of NY, VA.

    Quantity

    4 units