BD Vacutainer Tube Sodium Fluoride: 100 mg — Class II medical device recall Z-0095-2023
Ongoing recall by Becton Dickinson & Company, reported 2022-10-26, distributed nationwide. The affected product contains isobutylene which has recently demonstrated potential interference in determinat
| Recall number | Z-0095-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2022-09-15 |
| Classified | 2022-10-14 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, NZ |
| Quantity | 2,196,000 |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00382903670017, 30382903670018, 50382903670012 |
| Model numbers | 367001 |
Product
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Reason for recall
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0095-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.