BEUDAMED
    FDA Recall Open, Classified

    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

    Recall: Z-1255-2023 · Initiated February 14, 2023

    Recall

    Recall Number
    Z-1255-2023
    Event Number
    91704
    Firm
    Fenwal Inc
    FEI Number
    3004548776
    Product Code
    LKN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 14, 2023
    Posted
    March 15, 2023
    Address
    3 Corporate Dr, Ste 300, Lake Zurich, IL, 60047-8930

    Description

    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

    Reason

    Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.

    Action

    Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.

    Distribution

    Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.

    Quantity

    6,564 units