Recall Z-1883-2017— CareFusion 303, Inc.
Class II · Terminated
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-11-17, terminated 2018-10-29. It names one FDA 510(k) clearance: K970485. Product: SmartSite Add-On Bag Access Device, Model No. 10013365. Reason: 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..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-17
- Terminated
- 2018-10-29
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.