Recalls / —
—#126255
Product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K960280
- Affected lot / code info
- Lot No. 13085791
Why it was recalled
Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3299.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
Timeline
- Recall initiated
- 2014-03-19
- Posted by FDA
- 2014-04-16
- Terminated
- 2015-06-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.