BEUDAMED
    FDA Enforcement Class II Terminated

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    Recall: Z-2669-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2669-2014
    Event ID
    68874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genesis BPS, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    July 17, 2014
    Classification Date
    September 18, 2014
    Termination Date
    March 4, 2016
    Address
    65 Commerce Way, N/A, Hackensack, NJ, 07601-6302, United States

    Description

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    Reason

    Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

    Code Info

    Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301

    Distribution

    Nationwide Distribution & Switzerland

    Quantity

    4608 units