Recalls / Class II
Class IID-0371-2019
Product
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
- Affected lot / code info
- Lot # ASM0018348, EXP 12-31-2018
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.
Recalling firm
- Firm
- Bound Tree Medical, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1420 Lakeside Parkway, Dallas, Texas 75208
Distribution
- Quantity
- 84 kits
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2018-11-01
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-23
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0371-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.