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

Products covered by this recall
Model / numberProduct as published
10010511BD Extension Set SMALLBORE Tubing SmartSite VALVE
10010912BD SmartSite Extension Set Needle-Free Valve
10010983BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE
10011087BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV
10011253BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE)
10013902BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE
10014692BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR
10015488BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES
2000EBD SmartSite NEEDLE FREE VALVE
20021EBD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE
20035EBD Extension Set SMALLBORE Tubing SmartSite VALVE
20037EBD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER
20038EBD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES
20039EBD Extension Set SMALLBORE Tubing SmartSite VALVE
20057EBD Extension Set SmartSite VALVE SLIP LUER
20059EBD Extension Set SmartSite VALVE
20061EBD extension Set Y-CONNECTOR 2 SmartSite VALVES
20062EBD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES
20159EBD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE
20338EBD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE
Lot codes and dates
  • Lots

    1,173 of 1,173 codes

    • 20035964
    • 21016575
    • 20015157
    • 20025207
    • 20025243
    • 20025244
    • 20025245
    • 20025246
    • 20106552
    • 20115468
    • 20115469
    • 21039510
    • 20015758
    • 20055744
    • 20055745
    • 20075637
    • 20075638
    • 20075639
    • 20075673
    • 20096017
    • 20096018
    • 21016323
    • 20125462
    • 20016553
    • 20056551
    • 20076494
    • 20075342
    • 21026223
    • 20075341
    • 21016571
    • 20015128
    • 20015129
    • 20015130
    • 20015131
    • 20015132
    • 20015133
    • 20015134
    • 20015257
    • 20015258
    • 20015259
    • 20015260
    • 20015261
    • 20015908
    • 20015909
    • 20015910
    • 20015911
    • 20016199
    • 20016200
    • 20016201
    • 20016202
    • 20016545
    • 20016546
    • 20016547
    • 20016548
    • 20016549
    • 20016872
    • 20016873
    • 20016874
    • 20016876
    • 20017016
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.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.