Z-0930-2020 Class I Terminated

Recalled by Tytek Medical Inc — Blue Ash, OH

Recall Details

Product Type
Devices
Report Date
February 19, 2020
Initiation Date
November 15, 2019
Termination Date
October 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,565 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026