BEUDAMED
    FDA Enforcement Class II Terminated

    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"

    Recall: Z-2252-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2252-2013
    Event ID
    66060
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 25, 2013
    Initiation Date
    August 12, 2013
    Classification Date
    September 18, 2013
    Termination Date
    June 16, 2014
    Address
    87 Venture Drive, N/A, Dover, NH, 03820-5914, United States

    Description

    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"

    Reason

    Microbore tubing disconnecting from male luers on the extension sets.

    Code Info

    Lot Numbers: 1303022, 1304065

    Distribution

    Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

    Quantity

    3040