Reported Mar 2, 2022 · Ongoing
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a…
Becton Dickinson & Company
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815
Is this the product you have?
- 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
36490236490200
- Lot codes and dates
- All Lots within Expiry Catalog No364902
- UDI(01)50382903649025
- Catalog Number36490200
- UDI(01)60382903649022
- Amount recalled
- 288,152,790 Units
Where it was sold
- Nationwide
- IL
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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