Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BD SmartSite Recalled by CAREFUSION Due to Needle-free connector valves, either standalone or attached to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CAREFUSION directly.
Affected Products
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D
Quantity: 23,786,178
Why Was This Recalled?
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CAREFUSION
CAREFUSION has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report