Z-0221-2016Class II

SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or...

Name: Z-0221-2016 SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or...
Creator: CareFusion 303, Inc.
Published: 2015-10-09
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2015-10-09 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein on 2015-10-09. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues". 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-0221-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-09
Posted: 2015-11-05
Terminated: 2017-03-02
Recalling firm: CareFusion 303, Inc
Product: SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the 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 technical questions are instructed to contact Technical Support at (888) 812-3229.
Quantity in commerce: 21,000 units
Distribution: Distributed US (nationwide) and in Canada.
Product codes and lots: Lot No. 15015769, 15035412, 15045950.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0221-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0221-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

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)