BEUDAMED
    FDA Enforcement Class II Terminated

    Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

    Recall: Z-1228-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1228-2017
    Event ID
    76237
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    February 22, 2017
    Termination Date
    September 6, 2018
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

    Reason

    There have been complaints for peel away sheaths flaring

    Code Info

    Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS

    Distribution

    Nationwide Distribution

    Quantity

    215,703 units