CLASS II Drug recall · Reported 30 Jan 2019 · FDA Enforcement Report
curaplex Epi Safe Kit recalled by Bound Tree Medical
Bound Tree Medical is recalling curaplex Epi Safe Kit, 8600-01101, contains:" Vial of Epinephrine " 1 Epi-Safe Syringe ", distributed nationwide in the US. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.
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-0384-2019
- FDA event ID
- 81344
- Recalling firm
- Bound Tree Medical, Dallas, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2018
- FDA classified
- 18 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 2 Nov 2018 | Recall initiated by company | |
| 18 Jan 2019 | Classified by FDA | +77 days |
| 30 Jan 2019 | Published in enforcement report | +12 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 Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Product as listed by the FDA
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
Where it was distributed
Nationwide in the USA
Questions about this recall
Is curaplex Epi Safe Kit, 8600-01101, contains:" Vial of Epinephrine " 1 Epi-Safe Syringe " recalled?
Yes. Bound Tree Medical recalled curaplex Epi Safe Kit, 8600-01101, contains:" Vial of Epinephrine " 1 Epi-Safe Syringe " on 2 Nov 2018. The recall is Class II and its status is Terminated. Recall number D-0384-2019.
Why was it recalled?
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Which lots are affected?
all lot numbers
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 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 |
| Drug | CLASS III | Curaplex Epi Safe Kit recalled by Bound Tree Medical | Bound Tree Medical | Labeling Errors | Nationwide |