BEUDAMED
    FDA Enforcement Class II Terminated

    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310

    Recall: Z-2611-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2611-2023
    Event ID
    92899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tytek Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 27, 2023
    Initiation Date
    October 5, 2020
    Classification Date
    September 19, 2023
    Termination Date
    March 13, 2026
    Address
    8904 Beckett Rd, West Chester, OH, 45069-7054, United States

    Description

    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310

    Reason

    Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

    Code Info

    UDI: 00855204008020 All lots produced prior to Oct 5, 2020

    Distribution

    OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK

    Quantity

    4400 units