BEUDAMED
    FDA Recall Terminated

    Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    Recall: Z-2198-2008 · Initiated August 5, 2008

    Recall

    Recall Number
    Z-2198-2008
    Event Number
    49367
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 5, 2008
    Posted
    September 30, 2008
    Terminated
    July 25, 2012
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    Reason

    At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.

    Action

    Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.

    Distribution

    AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.

    Quantity

    150,000 pcs