Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SmartSite Add-On Bag Access Device Recalled by CareFusion 303, Inc. Due to CareFusion is recalling the SmartSite Add-On Bag Device...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 303, Inc. directly.
Affected Products
SmartSite Add-On Bag Access Device, Model No. 10013365
Quantity: 384,923 units
Why Was This 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.
Where Was This Sold?
US Distribution
About CareFusion 303, Inc.
CareFusion 303, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report