Tytek Medical Inc
Tytek Medical Inc appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2610-2023, Class II) was initiated on October 5, 2020.
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2610-2023 | Class II | TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the bo | October 5, 2020 |
| Z-2612-2023 | Class II | TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleu | October 5, 2020 |
| Z-2611-2023 | Class II | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into th | October 5, 2020 |
| Z-0930-2020 | Class I | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction | November 15, 2019 |