FDA recall Z-0930-2020

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-11-15

Report date

2020-02-19

Termination date

2020-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2020