Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
Bound Tree Medical is recalling Curaplex Epi Safe 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 agency classification is FDA Class II. The hazard involves the administration of an inappropriate dosage of epinephrine to children, which is a significant injury risk.
Plain-English summary
Bound Tree Medical, LLC is recalling 7,063 Curaplex Epi Safe Kits (Model 8600-01101) distributed nationwide in the USA. The kits contain a 1ml vial of epinephrine, an Epi-Safe Syringe, a safety needle, alcohol prep pads, an adhesive dressing, and an insert. The recall covers all lot numbers.
The recall was initiated because the Instructions for Use (IFU) recommend a midpoint dosage of epinephrine of 0.15mL for children between 0 and 66 lbs. This dosage has not been approved by the FDA for children. Reliance on these instructions may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, particularly those under 33 lbs. 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 should stop using the affected kits and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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.…
- Manufacturer
- Bound Tree Medical, LLC
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 →Related recalls
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- LowBound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
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