Home / Recalls / Medical Devices
CareFusion 303, Inc. recalls SmartSite Add-On Bag Access Device, Model No. 10013365
Recalled May 3, 2017 · FDA recall Z-1883-2017 · CareFusion 303
Hazard
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. · FDA Class II
Units
384,923 units
Sold at
US Distribution
Description
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.
Product
SmartSite Add-On Bag Access Device, Model No. 10013365
Manufacturer(s)
CareFusion 303, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →