West Chester, OH, United States
Tytek Medical Inc recalls
2 recalls recorded since 2018, most recently on 5 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 5 October 2020
- Terminated
- 13 March 2026
- 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
- Distribution
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2610-2023, Z-2612-2023, Z-2611-2023
- TyTek 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 tension pneumothorax Model Number: TM-303
- 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
- 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-31
Terminated Class I Medical devices
- Recall started
- 15 November 2019
- Terminated
- 1 October 2020
- Reason
- A defect involving an occluded needle was discovered during a training exercise.
- Distribution
- US (nationwide), and countries of: Europe, Australia and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0930-2020
- PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.