BEUDAMED
    FDA Enforcement Class II Terminated

    Multi-Lumen Central Venous Catheterization Kit

    Recall: Z-0076-2015 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0076-2015
    Event ID
    69290
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2014
    Initiation Date
    September 18, 2014
    Classification Date
    October 16, 2014
    Termination Date
    December 2, 2014
    Address
    2400 Bernville Road, N/A, Reading, PA, 19605, United States

    Description

    Multi-Lumen Central Venous Catheterization Kit

    Reason

    Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.

    Code Info

    Catolog No - AK-12703 lot number RF3039028

    Distribution

    US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.

    Quantity

    65