FDA Device recall Z-2610-2023
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from th…
- FDA Device
- Class II
- terminated
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from th… by Tytek Medical, citing updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2610-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-05 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tytek Medical |
| Distribution | OH, SC, VA |
Product
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
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
Identifiers
| code_info | UDI: 00855204008006 All lots produced prior to Oct 5, 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2610-2023%22
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