BEUDAMED
    FDA Enforcement Class II Terminated

    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

    Recall: Z-2771-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2771-2016
    Event ID
    74898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    February 17, 2016
    Classification Date
    September 9, 2016
    Termination Date
    October 18, 2017
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

    Reason

    Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

    Code Info

    Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

    Distribution

    US Distribution to states of: NC, OH, FL, and MD.

    Quantity

    6,121 units in total