BEUDAMED
    FDA Recall Terminated

    16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.

    Recall: Z-2277-2012 · Initiated August 7, 2012

    Recall

    Recall Number
    Z-2277-2012
    Event Number
    62780
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    August 7, 2012
    Posted
    August 27, 2012
    Terminated
    January 7, 2013
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.

    Reason

    Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.

    Action

    Bard Access Systems sent an "URGENT: *16 FR HEMOSTAR* LONG-TERM HEMODIALYSIS CATHETER RECALL" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form and Inventory Reconciliation Form was enclosed for customers to complete and return via fax to 1-801-522-5674. Contact BAS Customer Service at 1-800-290-1689 for questions regarding this recall.

    Distribution

    National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.

    Quantity

    120 units