FDA-Device2023-09-27Class II
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
Tytek Medical Inc
Hazard
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Sold states
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Affected count
22,026 units
Manufactured in
8904 Beckett Rd, West Chester, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2023Don't want to check this manually?
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