BEUDAMED
    FDA Recall Open, Classified

    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

    Recall: Z-0212-2022 · Initiated October 4, 2021

    Recall

    Recall Number
    Z-0212-2022
    Event Number
    88852
    Firm
    Therakos, Inc.
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 4, 2021
    Address
    10 N High St, Ste 300, West Chester, PA, 19380-3014

    Description

    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

    Reason

    Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

    Action

    Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.

    Distribution

    IL

    Quantity

    Five (5) Cases -3 Kits/Case= 15 Kits