Curaplex Epi Safe Kit — Class III drug recall D-0379-2019
Terminated recall by Bound Tree Medical, LLC, reported 2019-01-23, distributed nationwide. Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however
| Recall number | D-0379-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bound Tree Medical, LLC, Dallas, TX, United States |
| Recall initiated | 2018-11-01 |
| Classified | 2019-01-16 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 747 kits |
| Reason classes | labeling |
| Lot numbers | ASM0020274 |
| Model numbers | 8600-01101 |
| Expiration dates | 2018-05-31 |
Product
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.
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-0379-2019. 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.