Tytek Medical Inc recalls PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facil…

Recall date

November 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0930-2020

FDA classification

Class I

Brand / firm

Tytek Medical Inc

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.