BEUDAMED
    FDA Recall Terminated

    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    Recall: Z-0947-2014 · Initiated July 2, 2013

    Recall

    Recall Number
    Z-0947-2014
    Event Number
    65667
    Firm
    Ecolab Inc
    FEI Number
    1000289767
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 2, 2013
    Posted
    February 10, 2014
    Terminated
    May 14, 2014
    Address
    370 Wabasha St N, Saint Paul, MN, 55102

    Description

    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    Reason

    Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

    Action

    The recall was conducted to the consumer/user level. The firm notified their direct consignees of the problem and the recall by written letter mailed on July 2, 2013. The notice requested the consignees to quarantine any recalled product on hand, and complete and return the response form by July 31, 2013. The consignees who further distributed the recalled product were asked to notify their consignees.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

    Quantity

    6,040 individual units