BD Vacutainer Luer Lok Access Device — Class III medical device recall Z-0665-2022
Ongoing recall by Becton Dickinson & Company, reported 2022-03-02, distributed nationwide. May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used
| Recall number | Z-0665-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2022-01-06 |
| Classified | 2022-02-23 |
| Reported by FDA | 2022-03-02 |
| Distributed | Nationwide (US) |
| Quantity | 288,152,790 units |
| UPC / GTIN / UDI-DI | 50382903649025, 60382903649022 |
| Model numbers | 364902, 36490200 |
Product
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
Reason for recall
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
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-0665-2022. 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.