TyTek PneumoDart- Intended for introduction into the body… recallZ-2612-2023 · Tytek Medical Inc · initiated Oct 5, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tytek Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2612-2023
- Status
- Terminated
- Initiated by the company
- Oct 5, 2020
- Posted by the FDA
- Sep 19, 2023
- Recalling firm
- Tytek Medical Inc
- Quantity
- 22,026 units
- Product code
- GAA
- Distribution
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Product description
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
Code information (models, lots, serial numbers)
UDI: 00855204008167 All lots produced prior to Oct 5, 2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PneumoDart TM-317TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 92899).
- Z-2610-2023 · TerminatedTyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tensi…
- Z-2611-2023 · TerminatedTyTek 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 t…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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