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Recall Observatory FDA recall evidence

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

November 15, 2019

Class I

Product summary

Firm
Tytek Medical Inc
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

    reason.no_named_rule · v1.0.0

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