Tytek Medical Inc Recall 92899
Description: TyTek Tension Pneumothorax Access Kit TPAK 14 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-303
Tytek Medical Inc Recall 92899 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2610-2023 |
| Event ID | 92899 |
| Event Description | TyTek Tension Pneumothorax Access Kit TPAK 14 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-303 |
| Product Type | Devices |
| Distribution | OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK |
| Quantity | 439146 units |
| Recall 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 |
| Device Classification | 20230927 |
| Device Code Info | UDI: 00855204008006 All lots produced prior to Oct 5, 2020 |
| Center Classification Date | 20230919 |
| Recall Initiation Date | 20201005 |
| Recalling Firm | Tytek Medical Inc |
| Initial Notification | |
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