Bound Tree Medical Curaplex Epi Safe Kit: Incorrect Expiration Date Labeling
Bound Tree Medical recalls Curaplex Epi Safe Kit (Rx Only) due to incorrect expiration date labeling and missing 510(k) clearance on the syringe. Affected units expire May 2019 but labeled as May 2018.
Lower-risk recall
Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
Contact the company
What happened, in plain English
Bound Tree Medical is recalling Curaplex Epi Safe Kits because the expiration date on the label is incorrect (labeled as May 2018 but should be May 2019) and the syringe lacks 510(k) clearance. This could lead to improper use if the kit is used after the correct expiration date or without proper regulatory approval. Read more at govinfonow.com/recall/39458-bound-tree-medical-curaplex-epi-safe-kit-incorrect-expiration-date.
Source Summary by GovInfoNow · govinfonow.com/recall/39458-bound-tree-medical-curaplex-epi-safe-kit-incorrect-expiration-date · Updated October 5, 2026 · FDA enforcement record: FDA #D-0379-2019
Cite this page
“Bound Tree Medical Curaplex Epi Safe Kit: Incorrect Expiration Date Labeling.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39458-bound-tree-medical-curaplex-epi-safe-kit-incorrect-expiration-date. Based on FDA recall #D-0379-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0379-2019%22&limit=1).
Why it’s dangerous
The kit has an incorrect expiration date label (showing May 2018 instead of May 2019) and the syringe lacks 510(k) clearance. This means the kit might expire earlier than intended or not meet regulatory safety standards for medical devices.
Who’s affected
People with prescriptions for Curaplex Epi Safe Kits are affected. Those who have the kit labeled with an expiration date of May 2018 but should expire in May 2019 are most at risk.
How to tell if you have this one
Check the expiration date on the label, which should read May 2019. The kit model number is 8600-01101 with lot number ASM0020274. It was distributed by Sarnova, HC. LLC.
- Brand
Bound Tree Medical- Category
Drug
What to do — step by step
Check Expiration Date
Verify the expiration date on the label is May 2019, not May 2018.
Contact Manufacturer
Reach out to Bound Tree Medical for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0379-2019 (November 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0379-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.