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Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety n...

FDA Recall #D-0379-2019 — Class III — November 1, 2018

Recall #D-0379-2019 Date: November 1, 2018 Classification: Class III Status: Terminated

Product Description

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 Products, Inc. & Tri-amin Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016. Model 8600-01101

Reason for Recall

Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.

Recalling Firm

Bound Tree Medical, LLC — Dallas, TX

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

747 kits

Distribution

Nationwide in the USA

Code Information

LOT # ASM0020274 Exp 5/31/2018

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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