Bound Tree Medical, LLC Recall: curaplex Epi Safe Administration and Training Kits, #8600-
Bound Tree Medical, LLC Recall: curaplex Epi Safe Administration and Training Kits, #8600- is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Bound Tree Medical, LLC; Product: curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01
| Recalling firm | Bound Tree Medical, LLC |
|---|---|
| Product | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 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 Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 |
| Reason for recall | 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 sy |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide in the USA |
| Recall initiated | 20181102 |
| Recall number | D-0383-2019 |
| Category | drug |
| State | TX |
| Country | United States |
$29/mo
Try RecallGuard →