BEUDAMED
    FDA Recall Terminated

    Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.

    Recall: Z-1539-2009 · Initiated April 2, 2009

    Recall

    Recall Number
    Z-1539-2009
    Event Number
    52046
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 2, 2009
    Posted
    June 29, 2009
    Terminated
    December 4, 2009
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.

    Reason

    The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.

    Action

    All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard.

    Distribution

    Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.

    Quantity

    16,100 units