BEUDAMED
    FDA Enforcement Class II Terminated

    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

    Recall: Z-1845-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1845-2020
    Event ID
    85360
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TeDan Surgical Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 13, 2020
    Initiation Date
    July 16, 2019
    Classification Date
    May 1, 2020
    Termination Date
    September 14, 2021
    Address
    12615 W Airport Blvd Ste 200, N/A, Sugar Land, TX, 77478-6203, United States

    Description

    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

    Reason

    There was incorrect raw material used in the production of the identified lot.

    Code Info

    Lot: 0619

    Distribution

    US Nationwide distribution in the states of NJ.

    Quantity

    2 units