BEUDAMED
    FDA Enforcement Class II Terminated

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

    Recall: Z-0733-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0733-2016
    Event ID
    72910
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Owens & Minor Distribution, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    November 17, 2015
    Classification Date
    January 30, 2016
    Termination Date
    September 13, 2016
    Address
    9120 Lockwood Blvd, N/A, Mechanicsville, VA, 23116-2015, United States

    Description

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

    Reason

    MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.

    Code Info

    Item No. Lot No. Expiration Date: CBN1103 12113H08A Oct-15, CBN1103 13033H08A Feb-16, CBN1103 13053H08A Apr-16, CBN1103 14013H08A Dec-16, CBN1103 14043H08A Mar-17, CBN1103 14053H08A Apr-17, CBN1103 14083H08A Jul-17, CBN1103 14063H08A May-17, CBN1103 15013H08A Dec-17, CBN1103 14123H08A Nov-17, CBN1103 14113H08A Oct-17, CBN1103 15023H08A Jan-18, CBN1103 15033H08A Feb-18, CBN1103 15043H08A Mar-18, CBN1103 15053H08A Apr-18, CBN1103 15063H08A May-18, CBN1103 15073H08A Jun-18, CBN1103 15083H08A Jul-18.

    Distribution

    Nationwide Distribution.

    Quantity

    42,050