Z-0925-2014Class II

SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually...

Name: Z-0925-2014 SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually...
Creator: CareFusion 303, Inc.
Published: 2014-01-22
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2014-01-22 / Terminated

FDA source

CareFusion 303, Inc. began a recall of SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to... on 2014-01-22. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0925-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-22
Posted: 2014-02-03
Terminated: 2015-08-06
Recalling firm: CareFusion 303, Inc
Product: SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in
FDA root cause: Under Investigation by firm
Action: The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated January 22, 2014 to customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the listed lot numbers, contact CareFusion for a replacement of the affected lots, and if you have inventory of the listed products immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. All recalled product should be returned directly to the distributor from whom it was purchased. If you have any question, contact your distributor directly or call the CareFusion Support Center at numbers below. For recall related questions, customers are instructed to contact CareFusion Support center at (888) 562-6018. For adverse event reports, customers are instructed to contact Customer advocacy at (888) 812-3266 or email [email protected]. For technical questions regarding the Alaris System, customers are instructed to contact technical support at (888) 812-3229.
Quantity in commerce: 3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
Product codes and lots: Lot Numbers: 13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0925-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0925-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

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)