BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a ca
Summary
The FDA issued a Class III for BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device by Becton Dickinson & Company. 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 .
Details
Source
Device Recall
External ID
Z-0665-2022
Action Date
2022-03-02
Status
Ongoing
Category
device
Product 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
Lot/Code Info: All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Quantity Affected: 288,152,790 Units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-06
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 122 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0665-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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