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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 fac
Recalled February 19, 2020 · FDA recall Z-0930-2020 · Tytek Medical
Hazard
A defect involving an occluded needle was discovered during a training exercise. · FDA Class I
Units
3,565 units
Sold at
US (nationwide), and countries of: Europe, Australia and Hong Kong.
Description
A defect involving an occluded needle was discovered during a training exercise.
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.
Manufacturer(s)
Tytek Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →