The Recall Desk

FDA (Drugs) recall action 81344

Bound Tree Medical, LLC recalled 4 products on 2019-01-30

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-01-30
Critical
0
Units
—

Why these products were 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 s…

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • HighFDA (Drugs)··2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors

    Bound Tree Medical is recalling 2,654 Curaplex Epi Safe training kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, 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
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  • SevereFDA (Drugs)··2019-01-30

    Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions

    Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    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 Me
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    0 states
  • SevereFDA (Drugs)··2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions

    Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, L
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    0 states
  • SevereFDA (Drugs)··2019-01-30

    Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions

    Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    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., Eme
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    0 states