Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Curaplex Epi Safe Kit Recalled by Bound Tree Medical, LLC Due to Labeling Incorrect Instructions: This recall has been initiated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bound Tree Medical, LLC directly.
Affected Products
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
Quantity: 2,654 kits (6 syringes per kit / 1 IFU per kit)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bound Tree Medical, LLC
Bound Tree Medical, LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report