SmartSite Extension Set, Model No. 20029E, intravascular administration set.
FDA device recall Z-1459-2014 · posted 2014-04-16 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 7,700 units
- Distribution
- USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
- Date initiated
- 2014-03-19
- Date posted
- 2014-04-16
- Date terminated
- 2015-06-06
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (K960280) | Y | 1996-04-04 |