# FDA recall Z-2612-2023

> **Tytek Medical Inc** · Class II · device recall initiated 2020-10-05.

## 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

## 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

## Key facts

- **Recall number:** Z-2612-2023
- **Recalling firm:** Tytek Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-05
- **Report date:** 2023-09-27
- **Termination date:** 2026-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2023

## Citation

> AI Analytics. FDA recall Z-2612-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2612-2023. Source: US FDA. Licensed CC0.

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