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Tytek Medical Inc Recall: PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, devi

Tytek Medical Inc Recall: PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, devi is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Tytek Medical Inc; Product: PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facil

Recalling firmTytek Medical Inc
ProductPneumoDart, 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.
Reason for recallA defect involving an occluded needle was discovered during a training exercise.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionUS (nationwide), and countries of: Europe, Australia and Hong Kong.
Recall initiated20191115
Recall numberZ-0930-2020
Categorydevice
StateOH
CountryUnited States

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