# FDA recall Z-0930-2020

> **Tytek Medical Inc** · Class I · device recall initiated 2019-11-15.

## Product

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.

## Reason for recall

A defect involving an occluded needle was discovered during a training exercise.

## Distribution

US (nationwide), and countries of: Europe, Australia and Hong Kong.

## Key facts

- **Recall number:** Z-0930-2020
- **Recalling firm:** Tytek Medical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2020-02-19
- **Termination date:** 2020-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Blue Ash, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2020

## Citation

> AI Analytics. FDA recall Z-0930-2020. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0930-2020. Source: US FDA. Licensed CC0.

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