Recalls / —
—#149125
Product
SmartSite Add-On Bag Access Device, Model No. 10013365
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K970485
- Affected lot / code info
- 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
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.
Root cause (FDA determination)
Other
Action the firm took
CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy at (888) 812-3266 or by email at customerfeedback@carefusion.com. Customers are instructed to complete and return the enclosed mandatory customer response card.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- US Distribution
Timeline
- Recall initiated
- 2016-11-17
- Terminated
- 2018-10-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.