FDA Device recall 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…
- FDA Device
- Class I
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class I recall of 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… by Tytek Medical, citing A defect involving an occluded needle was discovered during a training exercise.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-11-15 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tytek Medical |
| Distribution | US |
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
A defect involving an occluded needle was discovered during a training exercise.
Identifiers
| code_info | NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2020%22
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