BEUDAMED
    FDA Recall Terminated

    MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device

    Recall: Z-2109-2010 · Initiated May 25, 2010

    Recall

    Recall Number
    Z-2109-2010
    Event Number
    56130
    Firm
    Microtek Medical Inc
    FEI Number
    1043582
    Product Code
    FYD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2010
    Posted
    July 28, 2010
    Terminated
    August 12, 2010
    Address
    602 N Lehmberg Rd, Columbus, MS, 39702-4406

    Description

    MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device

    Reason

    Product labeled as sterile was distributed without sterilization.

    Action

    The firm notified its consignees of the problem and requested return of the product by telephone on 05/25/2010. They followed with a letter dated on 06/03/2010 re: Product Removal stating the reason for the recall and confirming the receipt of the recalled product. For further information please contact (662) 244-3220

    Distribution

    Nationwide distribution including the states of Montana and Georgia

    Quantity

    2 cases of 10 units