# FDA recall Z-0665-2022

> **Becton Dickinson & Company** · Class III · device recall initiated 2022-01-06.

## 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

## Distribution

US Nationwide distribution in the state of IL.

## Key facts

- **Recall number:** Z-0665-2022
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-06
- **Report date:** 2022-03-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2022

## Citation

> AI Analytics. FDA recall Z-0665-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0665-2022. Source: US FDA. Licensed CC0.

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