BEUDAMED
    FDA Enforcement Class III Terminated

    Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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-0528-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0528-2014
    Event ID
    65734
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    November 21, 2012
    Classification Date
    December 17, 2013
    Termination Date
    March 12, 2014
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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

    Boxes labeled as CIP5 may contain cartridges of AMP5.

    Code Info

    Lot number: 1220205, exp July 21, 2015

    Distribution

    Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.

    Quantity

    60/5/50-disc cartridge boxes