BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1255-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1255-2023
    Event ID
    91704
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fenwal Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    March 15, 2023
    Address
    3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, 60047-8930, United States

    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.

    Code Info

    Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.

    Distribution

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

    Quantity

    6,564 units