BEUDAMED
    FDA Recall Terminated

    Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA. This is a Pain Management Product that is sold in a wide variety of kits including both standard tray configurations and custom kits.

    Recall: Z-0864-06 · Initiated March 15, 2006

    Recall

    Recall Number
    Z-0864-06
    Event Number
    35158
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    FPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 15, 2006
    Posted
    May 16, 2006
    Terminated
    May 10, 2011
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA. This is a Pain Management Product that is sold in a wide variety of kits including both standard tray configurations and custom kits.

    Reason

    There exists a possibility that the Pain Management Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device).

    Action

    Consignees were notified via fax on/about 03/15/2006.

    Distribution

    Nationwide. AK, AL, CA, CO, CT, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, OK, OR, PA, TX, UT, WA, WI.

    Quantity

    925 each