FDAFDA · Food and drugs·Recall number D-0371-2019
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
Published January 23, 2019 · Recall initiated: November 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bound Tree Medical, LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # ASM0018348, EXP 12-31-2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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