curaplex Epi Safe Administration and Training Kits # 8600-01100 — Class II drug recall D-0371-2019
Terminated recall by Bound Tree Medical, LLC, reported 2019-01-23, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on Dece
| Recall number | D-0371-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bound Tree Medical, LLC, Dallas, TX, United States |
| Recall initiated | 2018-11-01 |
| Classified | 2019-01-14 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 84 kits |
| Reason classes | labeling |
| Lot numbers | ASM0018348 |
| Expiration dates | 2018-12-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0371-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.