Z-0665-2022 Class III Ongoing
FDA device recall Z-0665-2022 was initiated by Becton Dickinson & Company on Jan 6, 2022 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 288,152,790 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2022
- Initiation Date
- Jan 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288,152,790 Units
Product Description
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 Pattern
US Nationwide distribution in the state of IL.
Code Information
All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0665-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026