Bound Tree Medical is recalling 11,339 Curaplex Epi-Safe Administration and Training Kits because the included Instructions for Use (IFU) recommend an unapproved dose of epinephrine (adrenaline) for children. These kits, including models 8600-01100, 8600-01101, 8600-01102, and 8600-01120, contain syringes and epinephrine vials used to treat severe allergic reactions (anaphylaxis). The instructions incorrectly suggest a 0.15mL dose for children under 66 pounds, and some syringes in the kits lack the necessary markings for healthcare providers to accurately measure doses for children under 33 kilograms (approximately 72 pounds). Consumers should contact their healthcare provider or the manufacturer immediately.
Following the incorrect instructions could lead to a child receiving an improper amount of epinephrine during a life-threatening allergic reaction. This is particularly dangerous for young children weighing less than 33 pounds, as they may receive an inappropriate dosage that fails to stop the reaction or causes adverse effects.
Drug recall remedy
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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