Becton Dickinson & Company Recall 89486
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
Becton Dickinson & Company Recall 89486 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0665-2022 |
| Event ID | 89486 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of IL. |
| Quantity | 288,152,790 Units |
| Recall 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 |
| Device Classification | 20220302 |
| Device Code Info | All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022 |
| Center Classification Date | 20220223 |
| Recall Initiation Date | 20220106 |
| Recalling Firm | Becton Dickinson & Company |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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