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-0734-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0734-2016
    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: CBN1104 15023H09A Jan-18, CBN1104 15033H09A Feb-18, CBN1104 15043H09A Mar-18, CBN1104 15053H09A Apr-18, CBN1104 15063H09A May-18, CBN1104 15073H09A Jun-18, CBN1104 15083H09A Jul-18, CBN1104 14113H09A Oct-17, CBN1104 14123H09A Nov-17, CBN1104 15013H09A Dec-17, CBN1104 14063H09A May-17, CBN1104 14083H09A Jul-17, CBN1104 14093H09A Aug-17, CBN1104 14053H09A Apr-17, CBN1104 14043H09A Mar-17, CBN1104 14013H09A Dec-16, CBN1104 13053H09A Apr-16, CBN1104 12113H09A Oct-15, CBN1104 13033H09A Feb-16, CBN1104 13083H09A Jul-16, CBN1104 13083H09A Jul-16, CBN1104 13103H09A Sep-16, CBN1104 13113H09A Oct-16, CBN1104 13123H09A Nov-16.

    Distribution

    Nationwide Distribution.

    Quantity

    96266