Reported May 3, 2017 · Terminated
SmartSite Add-On Bag Access Device, Model No. 10013365
CareFusion 303, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
- SmartSite Add-On Bag Access Device, Model No. 10013365
- Lot codes and dates
1505514615055702150562991505661815065645150757401507616615076167150766641507672915077085150850311508515615086107150950141509541115106928151169281512595215126069151274131601532416015325160156071602582416025948160270081603552716036131
- Amount recalled
- 384,923 units
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.
This product could cause temporary or reversible health problems — stop using it.
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