Bound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issues are limited to incorrect expiration date labeling and missing regulatory clearance for a component, with no reported injuries or illnesses.
Plain-English summary
Bound Tree Medical, LLC is recalling 747 units of the Curaplex Epi Safe Kit, a prescription-only medical device. The kits contain a 1mL vial of epinephrine, an Epi-Safe syringe, a safety needle, two alcohol prep pads, an adhesive dressing, and an insert. The product was distributed nationwide in the USA by Sarnova, HC. LLC's family companies, including Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc., and Tri-amin Health Services, Inc.
The recall was initiated due to labeling errors and regulatory non-compliance. The kits are incorrectly labeled with an expiration date of May 2018, whereas the correct expiration date is May 2019. Additionally, the syringe component of the device lacks the required 510(k) clearance from the FDA.
The affected product is identified by Lot # ASM0020274. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the affected kits. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Product
- Manufacturer
- Bound Tree Medical, LLC
- Affected units
- 747
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)
- LOT # ASM0020274 Exp 5/31/2018
Distribution
Distributed nationwide across the United States.
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