BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

    Recall: Z-0808-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0808-2013
    Event ID
    63556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    August 21, 2012
    Classification Date
    February 12, 2013
    Termination Date
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

    Reason

    The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

    Code Info

    Lot 1186069

    Distribution

    US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,

    Quantity

    23 units