Bound Tree Medical, LLC is recalling 747 Curaplex Epi Safe Kits (model 8600-01101), which are prescription-only emergency kits containing epinephrine and related administration supplies. These kits are being recalled because the external packaging incorrectly states an expiration date of May 2018, when the correct date is May 2019, and because the included syringe component lacks required 510(k) regulatory clearance. Affected kits were distributed nationwide across the United States between November 2018 and January 2019.
The incorrect expiration date labeling could cause users to prematurely discard potentially life-saving medication or lead to confusion during an emergency. Furthermore, the use of a syringe that has not received proper regulatory clearance means its safety and performance standards have not been fully verified for medical use.
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Sources: FDA iRES · Raw API Response
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