BEUDAMED
    FDA Enforcement Class III 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 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2277-2012
    Event ID
    62780
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    August 7, 2012
    Classification Date
    August 27, 2012
    Termination Date
    January 7, 2013
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    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.

    Code Info

    Product Code 5883730 lot number REVK0125.

    Distribution

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

    Quantity

    120 units