Recall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials
Bound Tree Medical is recalling 84 Curaplex Epi Safe Administration and Training Kits because the epinephrine vials inside expired in December 2018, despite the outer label showing January 2020.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates and a potential regulatory clearance issue, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Bound Tree Medical, LLC is recalling 84 units of the Curaplex Epi Safe Administration and Training Kit, catalog number 8600-01100. The recall is due to a labeling error where the epinephrine vials contained within the kits expired in December 2018, while the outer kit label incorrectly displays an expiration date of January 2020. Additionally, the syringe component of the device may lack 510(k) clearance.
The affected kits are identified by Lot # ASM0018348. These prescription-only kits were distributed nationwide in the United States by Sarnova HC, LLC's family of companies, including Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc., and Tri-anim Health Services, Inc.
Consumers and healthcare providers should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 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.…
- Manufacturer
- Bound Tree Medical, LLC
- Affected units
- 84
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 (2)
- Lot # ASM0018348
- EXP 12-31-2018
Distribution
Distributed nationwide across the United States.
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