Device 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.
Z-0930-2020
Product summary
- Event
- Event 84296
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,565 units
- Official record key
device-enforcement:Z-0930-2020
Official wording
Reason: A defect involving an occluded needle was discovered during a training exercise.
Code information: NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
Distribution pattern: US (nationwide), and countries of: Europe, Australia and Hong Kong.
Derived failure modes
-
Unknown
A defect involving an occluded needle was discovered during a training exercise.