CareFusion 303, Inc. recalls SmartSite Add-On Bag Access Device, Model No. 10013365
- Recall date
- November 17, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1883-2017
- FDA classification
- Class II
- Brand / firm
- CareFusion 303, Inc.
- Sold / distributed
- US Distribution
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SmartSite Add-On Bag Access Device, Model No. 10013365
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