FDAFDA · Food and drugs·Recall number Z-1883-2017
SmartSite Add-On Bag Access Device, Model No. 10013365
Published May 3, 2017 · Recall initiated: November 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- US Distribution
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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