Reported Jan 23, 2019 · Terminated
Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep…
Bound Tree Medical, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bound Tree Medical, LLC · 1420 Lakeside Parkway · Dallas, TX · 75208
Is this the product you have?
- Curaplex Epi Safe Kit, Rx Only
- contains
1mL Vial of Epinephrine1 Epi-Safe Syringe1 Safety needle2 Alcohol Prep Pads1 Adhesive Dressing1 Insert. Distributed by SarnovaHC
- LLC's family companiesBound 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
- Lot codes and dates
- LOT # ASM0020274 Exp 5/31/2018
- Amount recalled
- 747 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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