SmartSite Add-On Bag Access Device, Model No. 10013365
Reported: May 3, 2017 Initiated: November 17, 2016 #Z-1883-2017
Product Description
SmartSite Add-On Bag Access Device, Model No. 10013365
Reason for Recall
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.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 384,923 units
- Distribution
- US Distribution
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
SmartSite Add-On Bag Access Device, Model No. 10013365. Recalled by CareFusion 303, Inc.. Units affected: 384,923 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2017. Severity: Moderate. Recall number: Z-1883-2017.
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