Home / Recalls / Bound Tree Medical, LLC / D-0379-2019

D-0379-2019 Class III Terminated

Recalled by Bound Tree Medical, LLC — Dallas, TX

Recall Details

Product Type
Drugs
Report Date
January 23, 2019
Initiation Date
November 1, 2018
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
747 kits

Product Description

Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-amin Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016. Model 8600-01101

Reason for Recall

Labeling: 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.

Distribution Pattern

Nationwide in the USA

Code Information

LOT # ASM0020274 Exp 5/31/2018

Other recalls by Bound Tree Medical, LLC

  • Z-2532-2020 Class II — Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KL (May 14, 2020)
  • D-0385-2019 Class II — Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova (November 2, 2018)
  • D-0384-2019 Class II — curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-S (November 2, 2018)
  • D-0383-2019 Class II — curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi (November 2, 2018)
  • D-0386-2019 Class II — Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains: (November 2, 2018)
  • D-0371-2019 Class II — curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 (November 1, 2018)