Reported Sep 22, 2021 · Ongoing
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle…
Carefusion
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: CAREFUSION · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
15 of 15 products
| Model / number | Product as published |
|---|---|
2000E | BD SmartSite, CHINA |
2000E-04 | BD SmartSite Connector |
20021E7D | BD SmartSite J-LOOP Extension Set One Needle Free Valve |
20037E7D | BD SmartSite Extension Set One Needle Free Valve Slip Luer |
20038E7D | BD SmartSite Extension Set 3 Needle Free Valves |
20039E7D | BD SmartSite Extension Set One Needle Free Valve |
| — | BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D |
20059E-0006 | BD Extension Set 1 Needle-Free Valve |
20060E7D | BD SmartSite Extension Set 1 Needle-Free Valve |
20061E7D | BD SmartSite Extension Set 2 Needle Free Valves |
20062E7D | BD SmartSite Extension Set Check Valve 3 Needle Free Valves |
20159E7D | BD SmartSite Extension Set 2 Needle Free Valves |
60103E | BD Alaris GP Series SmartSite Burette Set |
63441E | BD Alaris GP Series Burette Set No Filter |
2000E7D | Alaris SmartSite needle-free valve |
- Lot codes and dates
- Lots
734 of 734 codes
200252402002524120025242200562252005623120056229200562302102582021025823210258242102582521025829200366902003669120036692200366942003698320046920200469212004692220055220200552212005522220055223200553792005538020055381200553822005550320055504200555052005550620055507200555082005588020055881200558822005588320055884200558852005588620055887200558882005588920055890200651002006510120065102200651042006510320065105200651062006510720065108200651092006511020065111200659862006598720065988
- Lots
- Amount recalled
- 23,786,178
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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