Recall Z-2611-2023— Tytek Medical Inc
Class II · Terminated
Class II FDA medical device recall by Tytek Medical Inc, initiated 2020-10-05, terminated 2026-03-13. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.
- Recalling firm
- Tytek Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-05
- Terminated
- 2026-03-13
- Firm location
- West Chester, OH, United States
Product description
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
Reason for recall
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Data sourced from openFDA. This site is unofficial and independent of the FDA.