Tytek Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-0930-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: November 15, 2019

Date Posted: February 19, 2020

Recall Number: Z-0930-2020

Event ID: 84296

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,565 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated