Recalls / Class III
Class IIID-0379-2019
Product
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
- Affected lot / code info
- LOT # ASM0020274 Exp 5/31/2018
Why it was recalled
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
- Firm
- Bound Tree Medical, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1420 Lakeside Parkway, Dallas, Texas 75208
Distribution
- Quantity
- 747 kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-11-01
- FDA classified
- 2019-01-16
- Posted by FDA
- 2019-01-23
- Terminated
- 2020-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0379-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.