Recall Z-2612-2023
Tytek Medical Inc · initiated October 5, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
Codes / lots: UDI: 00855204008167 All lots produced prior to Oct 5, 2020
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
FDA-determined 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.
Details
- Recall number
- Z-2612-2023
- Initiated
- October 5, 2020
- Posted by FDA
- September 19, 2023
- Terminated
- March 13, 2026
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 22,026 units
- Distribution
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
- Recalling firm
- Tytek Medical Inc, West Chester, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2610-2023 Class II | TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction…Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2)… | 10/05/2020Terminated |
| Z-2611-2023 Class II | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for…Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2)… | 10/05/2020Terminated |