Recalls / Class II
Class IID-0384-2019
Product
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
- Affected lot / code info
- all lot numbers
Why it was recalled
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Recalling firm
- Firm
- Bound Tree Medical, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1420 Lakeside Parkway, N/A, Dallas, Texas 75208
Distribution
- Quantity
- 7,063 kits (1 syringe per kit / 1 IFU per kit)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-11-02
- FDA classified
- 2019-01-18
- Posted by FDA
- 2019-01-30
- Terminated
- 2020-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0384-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.