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, 36490
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company has recalled BD Vacutainer Luer Lok Access Devices nationwide, with distribution identified in Illinois. The devices, which are sterile, single-use connectors designed to attach to catheter ports with threaded female luers, may shed contaminant particles into urine specimens. When used with Sysmex UF-1000i or UX-2000 Analyzers, these particles can be misidentified as red blood cells, resulting in falsely elevated red blood cell counts in test results. The recall affects approximately 288 million units across all lots of Catalog Number 36490200 and 364902 (with UDI codes 60382903649022 and 50382903649025, respectively) within their expiration dates.
The recall source does not specify a remedy or action that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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. Quantity: 288,152,790 Units Lot/code info: All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.