BEUDAMED
    FDA Enforcement Class II Terminated

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    Recall: Z-2779-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2779-2020
    Event ID
    85898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HF Acquisition Co. LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    August 10, 2020
    Termination Date
    February 1, 2022
    Address
    11629 49th Pl W, N/A, Mukilteo, WA, 98275-4255, United States

    Description

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    Reason

    A missing component (hand suction pump) in the emergency medical kits.

    Code Info

    STAT KIT Z-1000 Emergency Medical Kit Part Number: 1003550 AMBU Res-Cue Pump part number: 1004330

    Distribution

    US Nationwide distribution including in the states of TN and UT.

    Quantity

    2 kits