Device recall

Z-2610-2023: TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for…

FDA device recall · Class II · Tytek Medical Inc

Key facts

Recall number (Z-number) Z-2610-2023
Recall event 92899
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
Product code GAA
Recalling firm Tytek Medical Inc
Recall class Class II
Status Terminated
Termination date Mar 13, 2026
FEI number 3004551550

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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