Bound Tree Medical Epi-Safe Kit: Incorrect Dosage Instructions Risk for Young Children
Bound Tree Medical recalls Epi-Safe Kit 8600-01120 due to incorrect dosage instructions for children under 33 lbs. that may lead to unsafe epinephrine administration during anaphylaxis. Affected kits contain Safety-LOK Syringes with unapproved dosage markings.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Bound Tree Medical is recalling Epi-Safe Kits 8600-01120 because the instructions for use recommend an unapproved dosage of epinephrine for children under 33 lbs. This could lead to dangerous overdose if used incorrectly during anaphylaxis emergencies. Read more at govinfonow.com/recall/39443-bound-tree-medical-epi-safe-kit-incorrect-dosage-instructions-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39443-bound-tree-medical-epi-safe-kit-incorrect-dosage-instructions-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0386-2019
Cite this page
“Bound Tree Medical Epi-Safe Kit: Incorrect Dosage Instructions Risk for Young Children.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39443-bound-tree-medical-epi-safe-kit-incorrect-dosage-instructions-risk. Based on FDA recall #D-0386-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2019%22&limit=1).
Why it’s dangerous
The Epi-Safe Kit includes syringes with instructions that recommend a dosage of epinephrine for children under 33 pounds that has not been approved by the FDA. This could lead to an overdose if the kit is used as directed for young children experiencing anaphylaxis. The syringes also lack proper markings to draw the correct dosage for children under 33 kg.
Who’s affected
Parents and caregivers of young children who use the Epi-Safe Kit 8600-01120 for anaphylaxis emergencies are most at risk. Children under 33 pounds who receive the kit may be affected by incorrect dosage instructions.
How to tell if you have this one
Check for the product name 'Epi-Safe Kit 8600-01120' which includes 2 Safety-LOK Syringes, 2 vials of epinephrine, and other medical supplies. The kit is distributed by Bound Tree Medical, LLC and sold with specific lot numbers.
- Brand
Bound Tree Medical- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0383-2019 | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 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 Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016; all lot numbers | 1,283 kits (8 syringes per kit / 3 IFU's per kit) |
| D-0384-2019 | 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; all lot numbers | 7,063 kits (1 syringe per kit / 1 IFU per kit) |
| D-0385-2019 | Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, 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; all lot numbers | 2,654 kits (6 syringes per kit / 1 IFU per kit) |
| D-0386-2019 | Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. 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; all lot numbers | 339 kits (1 standard syringe / 1 IFU per kit) |
What to do — step by step
Review Instructions for Use
Check if the kit's instructions recommend a dosage for children under 33 pounds that has not been approved by the FDA.
Contact Manufacturer
Reach out to Bound Tree Medical, LLC at 5000 Tuttle Crossing Blvd., Dublin, OH 43016 for specific guidance on the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0386-2019 (November 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0386-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.