BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

    Recall: Z-1246-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1246-2014
    Event ID
    67590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    February 18, 2014
    Classification Date
    March 20, 2014
    Termination Date
    June 25, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

    Reason

    Some of the discs may not be impregnated with the antibiotic.

    Code Info

    Lot 1174497, exp. 2015/04

    Distribution

    Nationwide Distribution

    Quantity

    40/5/50-disc cartridge packages