Device product
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
Z-2611-2023
Product summary
- Event
- Event 92899
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4400 units
- Official record key
device-enforcement:Z-2611-2023
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: 00855204008020 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