Agency classClass IIOur severity:Severe FDA (Drugs)·D-0383-2019·Announced 2019-01-30

Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions

Bound Tree Medical is recalling Epi Safe Administration and 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that reliance on the instructions may result in the administration of an inappropriate dosage of epinephrine to young children, which constitutes a risk of significant injury.

Plain-English summary

Bound Tree Medical, LLC is recalling 1,283 curaplex Epi Safe Administration and Training Kits (Lot #8600-01100). The kits contain two Epi Safe Administration Kits and one Epi Safe Training Kit. The products were distributed nationwide in the USA by Sarnova HC, LLC and its family of companies.

The recall was 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. Reliance on these 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 lacks the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

Consumers and health care providers should stop using the affected kits and contact the recalling firm for instructions on how to return the product.

The recalled product

Product: 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…
Manufacturer: Bound Tree Medical, LLC
Category: Medical Device — Syringes / Injection Devices
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 →

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