Medications & Supplements/Prescription Drugs

Bound Tree Medical, LLC: curaplex Epi Safe Kits Recalled for Expired Epinephrine and Labeling Errors

Agency Publication Date: January 14, 2019

Summary

Bound Tree Medical, LLC is recalling 84 curaplex Epi Safe Administration and Training Kits (Product # 8600-01100) because the epinephrine vials inside the kits expired in December 2018, while the outer kit label incorrectly lists an expiration date of January 2020. Each kit contains two administration sets and one training set intended for emergency use. Additionally, the syringe component included in the kit may not have the required 510(k) regulatory clearance. Consumers should contact their healthcare provider or pharmacist immediately, as the medication may not be effective if used past its true expiration date.

Risk

Using expired epinephrine may result in a lack of efficacy during a life-threatening allergic reaction (anaphylaxis), which could lead to serious injury or death. Furthermore, the inclusion of a syringe without verified regulatory clearance means its safety and performance standards have not been fully established for clinical use.

What You Should Do

Locate your curaplex Epi Safe Administration and Training Kit (Product # 8600-01100) and check the outer label and internal components for matching identifiers.
Identify if your kit is affected by checking for Lot # ASM0018348 with an outer label expiration date of January 2020 (1-2020).
Check the individual epinephrine vials inside the kit to see if they are marked with an expiration date of December 31, 2018 (12-31-2018).
If your kit matches Lot # ASM0018348, do not rely on it for emergency treatment of allergic reactions; contact your healthcare provider or pharmacist immediately for guidance on a replacement.
Return any unused or expired kits to the place of purchase for a refund and contact Bound Tree Medical, LLC at their Dallas, Texas headquarters for further instructions.
For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall remedy for expired medication and unvetted components.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: curaplex Epi Safe Administration and Training Kits (Kit # 8600-01100)

Model:

8600-01100

8600-01101 (Administration Kit)

8600-01102 (Training Kit)

Lot Numbers:

ASM0018348 (Exp 12-31-2018)

Date Ranges: Expiration date January 2020 (incorrectly labeled on outer kit), Expiration date December 31, 2018 (vials)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81504

Status: Resolved

Manufacturer: Bound Tree Medical, LLC

Sold By: Sarnova HC, LLC; Bound Tree Medical, LLC; Cardio Partners, Inc.; Emergency Medical Products, Inc.; Tri-anim Health Services, Inc.

Manufactured In: United States

Units Affected: 84 kits

Distributed To: Nationwide

Were You Affected by This Recall?

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Locate your curaplex Epi Safe Administration and Training Kit (Product # 8600-01100) and check the outer label and internal components for matching identifiers.

Identify if your kit is affected by checking for Lot # ASM0018348 with an outer label expiration date of January 2020 (1-2020).

Check the individual epinephrine vials inside the kit to see if they are marked with an expiration date of December 31, 2018 (12-31-2018).

If your kit matches Lot # ASM0018348, do not rely on it for emergency treatment of allergic reactions; contact your healthcare provider or pharmacist immediately for guidance on a replacement.

Return any unused or expired kits to the place of purchase for a refund and contact Bound Tree Medical, LLC at their Dallas, Texas headquarters for further instructions.

For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: curaplex Epi Safe Administration and Training Kits (Kit # 8600-01100)

Model:

8600-01100

8600-01101 (Administration Kit)

8600-01102 (Training Kit)

Lot Numbers:

ASM0018348 (Exp 12-31-2018)

Date Ranges: Expiration date January 2020 (incorrectly labeled on outer kit), Expiration date December 31, 2018 (vials)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81504

Status: Resolved

Manufacturer: Bound Tree Medical, LLC

Sold By: Sarnova HC, LLC; Bound Tree Medical, LLC; Cardio Partners, Inc.; Emergency Medical Products, Inc.; Tri-anim Health Services, Inc.

Manufactured In: United States

Units Affected: 84 kits

Distributed To: Nationwide