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curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administ...

FDA Recall #D-0371-2019 — Class II — November 1, 2018

Recall #D-0371-2019 Date: November 1, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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.

Recalling Firm

Bound Tree Medical, LLC — Dallas, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

84 kits

Distribution

Distributed Nationwide in the USA

Code Information

Lot # ASM0018348, EXP 12-31-2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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