FDA-Device2022-03-02Class III
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
Hazard
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
Sold states
US Nationwide distribution in the state of IL.
Affected count
288,152,790 Units
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2022Don't want to check this manually?
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