Tytek Medical Inc recalls TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patie…

Recall date

October 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2612-2023

FDA classification

Class II

Brand / firm

Tytek Medical Inc

Sold / distributed

OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK

Why it was recalled

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317