BEUDAMED
    FDA Recall Terminated

    Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)

    Recall: Z-0788-2010 · Initiated November 24, 2009

    Recall

    Recall Number
    Z-0788-2010
    Event Number
    53954
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 24, 2009
    Posted
    March 5, 2010
    Terminated
    January 18, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)

    Reason

    Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

    Action

    The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.

    Distribution

    The products were shipped to distributors in GA, MD, and VA.

    Quantity

    180 kits