BEUDAMED
    FDA Enforcement Class II Terminated

    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

    Recall: Z-1344-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1344-2021
    Event ID
    87407
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fenwal Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    February 25, 2021
    Classification Date
    April 2, 2021
    Termination Date
    April 18, 2023
    Address
    3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, 60047-8930, United States

    Description

    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

    Reason

    Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

    Code Info

    Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022)

    Distribution

    US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.

    Quantity

    2466 units