Drug product
curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016
D-0371-2019
Product summary
- Event
- Event 81504
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 kits
- Official record key
drug-enforcement:D-0371-2019
Official wording
Reason: Labeling: 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 (syringe) may lack 510(k) clearance.
Code information: Lot # ASM0018348, EXP 12-31-2018
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing