Home / Recalls / Tytek Medical Inc / Z-2611-2023

Z-2611-2023 Class II Terminated

Recalled by Tytek Medical Inc — West Chester, OH

Recall Details

Product Type: Devices
Report Date: September 27, 2023
Initiation Date: October 5, 2020
Termination Date: March 13, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4400 units

Product 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 for Recall

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

Distribution Pattern

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

Code Information

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