FDA Device recall Z-0665-2022
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equippe…
- FDA Device
- Class III
- ongoing
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class III recall of BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equippe… by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0665-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-01-06 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
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
Identifiers
| code_info | All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2022%22
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