Bound Tree Medical Epi Safe Kits Expired: Incorrect Labeling Risk
Bound Tree Medical recalls Epi Safe Administration Kits #8600-01100 with expired epinephrine vials (Dec 2018) but incorrect expiration label (Jan 2020).
Lower-risk recall
Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.
Contact the company
What happened, in plain English
Bound Tree Medical is recalling Epi Safe Administration Kits that contain expired epinephrine vials (expired December 2018) but are labeled with a January 2020 expiration date. This labeling error means the vials could be expired and ineffective if used for emergency epinephrine administration. Read more at govinfonow.com/recall/39456-bound-tree-medical-epi-safe-kits-expired-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39456-bound-tree-medical-epi-safe-kits-expired-incorrect-labeling-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0371-2019
Cite this page
“Bound Tree Medical Epi Safe Kits Expired: Incorrect Labeling Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39456-bound-tree-medical-epi-safe-kits-expired-incorrect-labeling-risk. Based on FDA recall #D-0371-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0371-2019%22&limit=1).
Why it’s dangerous
The vials of epinephrine in the kits expired on December 2018 but the outer kit label shows an expiration date of January 2020. This labeling error means the vials could be expired and ineffective if used for emergency epinephrine administration. The device component (syringe) may also lack 510(k) clearance, which is required for medical devices.
Who’s affected
People who own or use the recalled Epi Safe Administration Kits #8600-01100 (2 kits per package) are affected. Those with medical conditions requiring epinephrine injections are at higher risk.
How to tell if you have this one
Check for the product code #8600-01100 on the outer kit label. The kits contain 2 Epi Safe Administration Kits (8600-01101) and 1 Epi Safe Training Kit (8600-01102). They were distributed with lot #ASM0018348 and expired December 31, 2018.
- Brand
Bound Tree Medical- Category
Drug
What to do — step by step
Check Kit Expiration
Verify the outer kit label shows expiration date January 2020 while vials expired December 2018.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed 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 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0371-2019 (November 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0371-2019 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.