Device 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
Z-2612-2023
Product summary
- Event
- Event 92899
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,026 units
- Official record key
device-enforcement:Z-2612-2023
Official wording
Reason: Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Code information: UDI: 00855204008167 All lots produced prior to Oct 5, 2020
Distribution pattern: OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Derived failure modes
-
Unknown
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location