FDAClass IIIMarch 2, 2022

BD Vacutainer Luer Lok Access Device - intended as a recall

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…

Why was BD Vacutainer Luer Lok Access Device - intended as a 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022

Product
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…
Recalling firm
Becton Dickinson & Company
Quantity
288,152,790 Units
Distribution
US Nationwide distribution in the state of IL.
Recall date
March 2, 2022
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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