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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # ASM0018348, EXP 12-31-2018
Where it was sold
Distributed 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-0371-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2018
- FDA report date
- Jan 23, 2019
- Quantity
- 84 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bound Tree Medical, LLC
Original FDA data
Every field from FDA enforcement report D-0371-2019, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81504
- Address
- 1420 Lakeside Parkway
- Code information
- Lot # ASM0018348, EXP 12-31-2018
- Postal code
- 75208
- Report date
- Jan 23, 2019
- Product type
- Drugs
- Recall number
- D-0371-2019
- Classification
- Class II
- Recalling firm
- Bound Tree Medical, LLC
- Product quantity
- 84 kits
- Termination date
- Jan 24, 2020
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2019