Reported Feb 12, 2014 · Terminated

SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged…

CareFusion 303, Inc.

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 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386

Is this the product you have?

  • SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.
Lot codes and dates
  • Lot Numbers
    • 13045933
    • 13046117
    • 13086415
    • 13086446
    • 13095237
    • 13095302
    • 13095324
    • 13095579
    • 13095674
    • 13095675
    • 13095777
    • 13095778
    • 13095808
    • 13095944
    • 13096011
    • 13096012
    • 13096013
    • 13096158
    • 13096723
    • 13096770
    • 13105584
    • 13106017
    • 13106018
    • 13106096
    • 13106260
    • 13106355
    • 13106451
    • 13106497
    • 13106498
    • 13106753
    • 13106754
    • 13106847
    • 13106848
    • 13106849
    • 13115209
    • 13115210
    • 13115317
    • 13115733
    • 13115734
    • 13115871
    • 13115872
    • 13125361
    • 13125362
Amount recalled
3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 6, 2015 · Data as of Sep 19, 4:53 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.