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Recall Observatory FDA recall evidence

Device product

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

Z-1883-2017

November 17, 2016

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 75013
Status
Terminated
Classification
Class II
Quantity
384,923 units
Official record key
device-enforcement:Z-1883-2017

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.