BEUDAMED
    FDA Recall Terminated

    PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.

    Recall: Z-1525-2010 · Initiated March 18, 2010

    Recall

    Recall Number
    Z-1525-2010
    Event Number
    55175
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 18, 2010
    Posted
    April 29, 2010
    Terminated
    October 1, 2010
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.

    Reason

    8F PowerPort stems were mixed with 6F PowerPorts and packaged.

    Action

    The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.

    Distribution

    Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.

    Quantity

    200 units total (100 units of each lot, see code information)