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.
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
Lot numbers, UPCs & expiration codes
LOT # ASM0020274 Exp 5/31/2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0379-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 1, 2018
- FDA report date
- Jan 23, 2019
- Quantity
- 747 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bound Tree Medical, LLC
Original FDA data
Every field from FDA enforcement report D-0379-2019, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81487
- Address
- 1420 Lakeside Parkway
- Code information
- LOT # ASM0020274 Exp 5/31/2018
- Postal code
- 75208
- Report date
- Jan 23, 2019
- Product type
- Drugs
- Recall number
- D-0379-2019
- Classification
- Class III
- Recalling firm
- Bound Tree Medical, LLC
- Product quantity
- 747 kits
- Termination date
- May 11, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2019