FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: SmartSite Extension Set, Model No. 20029E, intravascular administration set.
- Recall number
- Z-1459-2014
- Recalling firm
- CareFusion 303, Inc.
- Product
- SmartSite Extension Set, Model No. 20029E, intravascular administration set.
- Status
- Terminated
- Initiated
- 2014-03-19
- Posted
- 2014-04-16
- Terminated
- 2015-06-06
- Reason
- Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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
- Lot, serial or model codes
- Lot No. 13085791
- 510(k) numbers
- ["K960280"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28