BEUDAMED
    FDA Recall Terminated

    Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801

    Recall: Z-2274-2010 · Initiated June 7, 2010

    Recall

    Recall Number
    Z-2274-2010
    Event Number
    55933
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 7, 2010
    Posted
    August 25, 2010
    Terminated
    September 29, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801

    Reason

    Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.

    Action

    June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.

    Distribution

    All affected product was distributed to one foreign consignee: Arrow Japan Ltd.

    Quantity

    3000 kits