BEUDAMED
    FDA Recall Terminated

    Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions

    Recall: Z-2493-2010 · Initiated July 29, 2010

    Recall

    Recall Number
    Z-2493-2010
    Event Number
    56363
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 29, 2010
    Posted
    September 25, 2010
    Terminated
    July 5, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions

    Reason

    Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

    Action

    The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.

    Distribution

    The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.

    Quantity

    15