BEUDAMED
    FDA Recall Terminated

    Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI

    Recall: Z-1936-2010 · Initiated March 16, 2010

    Recall

    Recall Number
    Z-1936-2010
    Event Number
    55885
    Firm
    Centurion Medical Products
    FEI Number
    1824619
    Product Code
    FKG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2010
    Posted
    June 30, 2010
    Terminated
    February 9, 2011
    Address
    301 Catrell Dr, Howell, MI, 48843-1703

    Description

    Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI

    Reason

    The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.

    Action

    The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.

    Distribution

    Nationwide Distribution -- AR and OH.

    Quantity

    3144 kits