Reported Sep 22, 2021 · Ongoing
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF:…
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?
26 of 26 products
| Model / number | Product as published |
|---|---|
10010511 | BD Extension Set SMALLBORE Tubing SmartSite VALVE |
10010912 | BD SmartSite Extension Set Needle-Free Valve |
10010983 | BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE |
10011087 | BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV |
10011253 | BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE) |
10013902 | BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE |
10014692 | BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR |
10015488 | BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES |
2000E | BD SmartSite NEEDLE FREE VALVE |
20021E | BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE |
20035E | BD Extension Set SMALLBORE Tubing SmartSite VALVE |
20037E | BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER |
20038E | BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES |
20039E | BD Extension Set SMALLBORE Tubing SmartSite VALVE |
20057E | BD Extension Set SmartSite VALVE SLIP LUER |
20059E | BD Extension Set SmartSite VALVE |
20061E | BD extension Set Y-CONNECTOR 2 SmartSite VALVES |
20062E | BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES |
20159E | BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE |
20338E | BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE |
- Lot codes and dates
- Lots
1,173 of 1,173 codes
200359642101657520015157200252072002524320025244200252452002524620106552201154682011546921039510200157582005574420055745200756372007563820075639200756732009601720096018210163232012546220016553200565512007649420075342210262232007534121016571200151282001512920015130200151312001513220015133200151342001525720015258200152592001526020015261200159082001590920015910200159112001619920016200200162012001620220016545200165462001654720016548200165492001687220016873200168742001687620017016
- Lots
- Amount recalled
- 20,874,700
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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