BEUDAMED
    FDA Enforcement Class III Terminated

    Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.

    Recall: Z-2430-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2430-2012
    Event ID
    62736
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Impact Instrumentation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    March 30, 2012
    Classification Date
    September 20, 2012
    Termination Date
    July 21, 2015
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206, United States

    Description

    Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.

    Reason

    A shipment mix-up took place.

    Code Info

    Model 324JL S/N 120142 and S/N 120144

    Distribution

    Nationwide distribution: USA including states of: FL and OH.

    Quantity

    2 devices