BEUDAMED
    FDA Recall 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 · Initiated August 12, 2013

    Recall

    Recall Number
    Z-2252-2013
    Event Number
    66060
    Firm
    Churchill Medical Systems, Inc.
    FEI Number
    1000120555
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 12, 2013
    Posted
    September 18, 2013
    Terminated
    June 16, 2014
    Address
    87 Venture Drive, Dover, NH, 03820-5914

    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.

    Action

    "Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414.

    Distribution

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

    Quantity

    3040