Reported May 3, 2017 · Terminated

SmartSite Add-On Bag Access Device, Model No. 10013365

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 Add-On Bag Access Device, Model No. 10013365
Lot codes and dates
    • 15055146
    • 15055702
    • 15056299
    • 15056618
    • 15065645
    • 15075740
    • 15076166
    • 15076167
    • 15076664
    • 15076729
    • 15077085
    • 15085031
    • 15085156
    • 15086107
    • 15095014
    • 15095411
    • 15106928
    • 15116928
    • 15125952
    • 15126069
    • 15127413
    • 16015324
    • 16015325
    • 16015607
    • 16025824
    • 16025948
    • 16027008
    • 16035527
    • 16036131
Amount recalled
384,923 units

Why it was recalled

CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.

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 Oct 29, 2018 · Data as of Sep 19, 4:45 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.