BEUDAMED
    FDA Recall Terminated

    B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.

    Recall: Z-2074-2010 · Initiated June 18, 2010

    Recall

    Recall Number
    Z-2074-2010
    Event Number
    56139
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    June 18, 2010
    Posted
    July 22, 2010
    Terminated
    July 21, 2010
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.

    Reason

    Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.

    Action

    The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.

    Distribution

    CA, PA, TN.

    Quantity

    2 units