BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

    Recall: Z-0734-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0734-2014
    Event ID
    67099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    November 21, 2013
    Classification Date
    January 14, 2014
    Termination Date
    December 11, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

    Reason

    Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Code Info

    Lot number: 1223566 EXP: 8/31/2013

    Distribution

    Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV

    Quantity

    45/5/50 - discs/cartridges/packs