BEUDAMED
    FDA Enforcement Class II Ongoing

    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

    Recall: Z-0212-2022 · Reported November 17, 2021

    Enforcement

    Recall Number
    Z-0212-2022
    Event ID
    88852
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Therakos, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 17, 2021
    Initiation Date
    October 4, 2021
    Classification Date
    November 5, 2021
    Address
    10 N High St Ste 300, N/A, West Chester, PA, 19380-3014, United States

    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.

    Code Info

    LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201

    Distribution

    IL

    Quantity

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