BEUDAMED
    FDA Enforcement Class II Ongoing

    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

    Recall: Z-0567-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0567-2022
    Event ID
    89383
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mallinckrodt Pharmaceuticals Ireland Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    February 16, 2022
    Initiation Date
    December 10, 2021
    Classification Date
    February 7, 2022
    Address
    College Business & Technology Park, Blanchardstown Road North, Dublin 15, N/A, N/A, Ireland

    Description

    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

    Reason

    This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.

    Code Info

    Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.

    Quantity

    3