Bound Tree Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2532-2020Class IICuraplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex May 14, 2020
D-0385-2019Class IICuraplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family ofNovember 2, 2018
D-0384-2019Class IIcuraplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 SafeNovember 2, 2018
D-0383-2019Class IIcuraplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe AdministrationNovember 2, 2018
D-0386-2019Class IICuraplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK SyringeNovember 2, 2018
D-0379-2019Class IIICuraplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needNovember 1, 2018
D-0371-2019Class IIcuraplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe AdministratNovember 1, 2018