BEUDAMED
    FDA Recall Terminated

    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    Recall: Z-1523-2013 · Initiated May 24, 2013

    Recall

    Recall Number
    Z-1523-2013
    Event Number
    65296
    Firm
    Fenwal Inc
    FEI Number
    3004548776
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 24, 2013
    Posted
    June 8, 2013
    Terminated
    August 1, 2016
    Address
    3 Corporate Dr, Ste 300, Lake Zurich, IL, 60047-8930

    Description

    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    Reason

    Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s

    Action

    Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925.

    Distribution

    USA Nationwide Distribution

    Quantity

    19 Cases (114 Units)