FDA Drug recall D-0371-2019
curaplex Epi Safe Administration and Training Kits # 8600-01100
- FDA Drug
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of curaplex Epi Safe Administration and Training Kits # 8600-01100 by Bound Tree Medical, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0371-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-01 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bound Tree Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot # ASM0018348, EXP 12-31-2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0371-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.