FDA-Device2017-05-03Class II
SmartSite Add-On Bag Access Device, Model No. 10013365
CareFusion 303, Inc.
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.
Sold states
US Distribution
Affected count
384,923 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
SmartSite Add-On Bag Access Device, Model No. 10013365
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2017Don't want to check this manually?
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