Bound Tree Medical recalls
FDA enforcement reports naming Bound Tree Medical, LLC as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Jan 30, 2019
- Jan 30, 2019curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe A…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syr…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LL…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 30, 2019Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safet…Drug · Bound Tree Medical, LLCLabeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a mi…Class II
- Jan 23, 2019curaplex Epi Safe Administration and Training Kits # 8600-01100Drug · Bound Tree Medical, LLCLabeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (s…Class II
- Jan 23, 2019Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe,…Drug · Bound Tree Medical, LLCLabeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.Class III