BEUDAMED
    FDA Recall Terminated

    Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.

    Recall: Z-0069-2010 · Initiated August 28, 2009

    Recall

    Recall Number
    Z-0069-2010
    Event Number
    53498
    Firm
    Unimed Surgical Products, Inc.
    FEI Number
    1000307745
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 28, 2009
    Posted
    October 21, 2009
    Terminated
    May 12, 2010
    Address
    10401 Belcher Rd, South Largo, FL, 33777-1415

    Description

    Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.

    Reason

    Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.

    Action

    Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall. For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.

    Distribution

    Nationwide Distribution -- MI

    Quantity

    1920 units