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
This recall is currently active, issued September 19, 2023. It was issued by Tytek Medical Inc.
- Company
- Tytek Medical Inc
- Recall Initiated
- October 5, 2020
- Posted
- September 19, 2023
- Recall Number
- Z-2611-2023
- Quantity
- 4400 units
- Firm Location
- West Chester, OH
- Official Source
- View on FDA website ↗
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
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Lot / Code Info
UDI: 00855204008020 All lots produced prior to Oct 5, 2020
Root Cause
Device Design
Action Taken
TyTek New Product IFU was initially sent out to all who purchased the product on 08Dec2020 with notification on what was updated. An official field safety notice (FSN) was sent to customers on 02Aug2021.The changes to the IFUs were proactive in nature. There has been no change to the Products themselves. When used in a manner consistent with the IFUs, the Products are safe for their intended use, and we wish to reiterate that there have been no incidents whatsoever. For you reference I have attached the IFU that we originally sent you in December 2020. Please do not hesitate to contact us should you have any additional questions. The change in our IFUs for these products was implemented to: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location.