BEUDAMED
    FDA Enforcement Class II Terminated

    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

    Recall: Z-1251-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1251-2016
    Event ID
    73324
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amd Ritmed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    February 24, 2016
    Classification Date
    March 25, 2016
    Termination Date
    July 8, 2016
    Address
    1200 Av 55e, N/A, Lachine, N/A, N/A, Canada

    Description

    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

    Reason

    Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

    Code Info

    Lot 63927, expiration 2017-04

    Distribution

    US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.

    Quantity

    126 cases total (87 cases domestically and 39 cases internationally)