Bound Tree Medical, LLC recalls curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101…

Recall date

November 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0371-2019

FDA classification

Class II

Brand / firm

Bound Tree Medical, LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016