Z-1459-2014Class II

SmartSite Extension Set, Model No. 20029E, intravascular administration set

Name: Z-1459-2014 SmartSite Extension Set, Model No. 20029E, intravascular administration set
Creator: CareFusion 303, Inc.
Published: 2014-03-19
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2014-03-19 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of SmartSite Extension Set, Model No. 20029E, intravascular administration set on 2014-03-19. FDA classified it as Class II and gives the reason as "Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1459-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Posted: 2014-04-16
Terminated: 2015-06-06
Recalling firm: CareFusion 303, Inc
Product: SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
Root cause tag: manufacturing process
FDA 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 [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3299.
Quantity in commerce: 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
Product codes and lots: Lot No. 13085791

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1459-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1459-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-15

Product code FPA

K960280Class IIIvac Needle Free Valve Administration SetsY / cleared 1996-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)