Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge Recalled by Tytek Medical Inc Due to Updated IFU to inlclude: (1) identify the risks...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tytek Medical Inc directly.
Affected Products
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
Quantity: 4400 units
Why Was This Recalled?
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Where Was This Sold?
This product was distributed to 3 states: OH, SC, VA
About Tytek Medical Inc
Tytek Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report