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.
What this means for you
Illness, injury, or structural failure has been reported. 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 Me
- 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
Same manufacturer · Bound Tree Medical, LLC
See all →- HighBound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-30
- SevereBound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions
FDA (Drugs) · 2019-01-30
- SevereRecall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
FDA (Drugs) · 2019-01-30
- LowBound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-23
- ModerateRecall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials
FDA (Drugs) · 2019-01-23
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