Agency classClass IIOur severity:High FDA (Drugs)·D-0385-2019·Announced 2019-01-30

Bound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors

Bound Tree Medical is recalling 2,654 Curaplex Epi Safe training kits because the instructions recommend an unapproved epinephrine dosage for young children.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (epinephrine dosing error) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Bound Tree Medical, LLC is voluntarily recalling 2,654 Curaplex Epi Safe Kits (Model 8600-01102) distributed nationwide in the United States. The recall is initiated because the Instructions for Use included in the kits recommend a midpoint dosage of epinephrine for children between 0 and 66 pounds that has not been approved by the FDA for children.

The incorrect instructions may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, particularly those under 33 pounds. 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. The affected product is labeled as "TRAINING ONLY" and "Rx Only."

Consumers and health care providers should stop using the affected kits and contact Bound Tree Medical, LLC for further instructions. The recall covers all lot numbers of the specified model.

The recalled product

Product: 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
Manufacturer: Bound Tree Medical, LLC
Category: Medical Device — Epinephrine Auto-Injector
Hazard: mis-labeling
incorrect-dosage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

all lot numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Bound Tree Medical, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Bound Tree Medical, LLC

See all →

Severe
Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions
FDA (Drugs) · 2019-01-30
Severe
Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions
FDA (Drugs) · 2019-01-30
Severe
Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
FDA (Drugs) · 2019-01-30
Low
Bound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-23
Moderate
Recall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials
FDA (Drugs) · 2019-01-23

Same hazard · mis labeling