CLASS III Drug recall · Reported 23 Jan 2019 · FDA Enforcement Report
Curaplex Epi Safe Kit recalled by Bound Tree Medical
Bound Tree Medical is recalling Curaplex Epi Safe Kit, distributed nationwide in the US. The recall was initiated on 1 Nov 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0379-2019
- FDA event ID
- 81487
- Recalling firm
- Bound Tree Medical, Dallas, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Nov 2018
- FDA classified
- 16 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Allergy Medication
Timeline
| 1 Nov 2018 | Recall initiated by company | |
| 16 Jan 2019 | Classified by FDA | +76 days |
| 23 Jan 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Curaplex Epi Safe Kit recalled?
Yes. Bound Tree Medical recalled Curaplex Epi Safe Kit on 1 Nov 2018. The recall is Class III and its status is Terminated. Recall number D-0379-2019.
Why was it recalled?
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.
Which lots are affected?
LOT # ASM0020274 Exp 5/31/2018
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bound Tree Medical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Curaplex Ambu King Lts-d Supraglottic Airway Kit with ET Tube recalled | Bound Tree Medical | Packaging Defects | Nationwide |
| Drug | CLASS II | curaplex Epi Safe Kit recalled by Bound Tree Medical | Bound Tree Medical | Other | Nationwide |
| Drug | CLASS II | curaplex Epi Safe Administration and Training Kits recalled | Bound Tree Medical | Other | Nationwide |
| Drug | CLASS II | Curaplex Epi Safe Kit, 8600-01102 Training Only recalled | Bound Tree Medical | Other | Nationwide |
| Drug | CLASS II | Curaplex Epi Kit NOT FOR IV USE, #8600 recalled by Bound Tree Medical | Bound Tree Medical | Other | Nationwide |