Tytek Medical Inc recalls PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, steril
Recalled 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.
Hazard / Issue
A defect involving an occluded needle was discovered during a training exercise.
Issued by
FDA
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