BEUDAMED
    FDA Recall Open, Classified

    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

    Recall: Z-0567-2022 · Initiated December 10, 2021

    Recall

    Recall Number
    Z-0567-2022
    Event Number
    89383
    Firm
    Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin
    FEI Number
    3013428851
    Product Code
    LNR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 10, 2021
    Address
    15 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.

    Action

    On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.

    Distribution

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

    Quantity

    3