D-0371-2019 Class II Terminated
FDA drug recall D-0371-2019 was initiated by Bound Tree Medical, LLC on November 1, 2018 and is designated Class II. Reason for recall: 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, … The recall status is terminated (terminated January 24, 2020). Affected quantity: 84 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- January 23, 2019
- Initiation Date
- November 1, 2018
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 kits
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # ASM0018348, EXP 12-31-2018