BEUDAMED
    FDA Enforcement Class II Terminated

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    Recall: Z-0945-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0945-2014
    Event ID
    65667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    July 2, 2013
    Classification Date
    February 10, 2014
    Termination Date
    May 14, 2014
    Address
    370 Wabasha St N, N/A, Saint Paul, MN, 55102, United States

    Description

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, 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.

    Code Info

    Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V

    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

    12,546 individual units