FDA recall Z-2612-2023

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-10-05

Report date

2023-09-27

Termination date

2026-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2023