Z-0450-2014Class II

SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low...

Name: Z-0450-2014 SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low...
Creator: CareFusion 303, Inc.
Published: 2013-11-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-11-08 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to... on 2013-11-08. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing". 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-0450-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2013-12-04
Terminated: 2014-05-27
Recalling firm: CareFusion 303, Inc
Product: SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are 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 Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated November 8, 2013 to all customers who purchased the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card and return all recalled product directly to the distributor form whom it was purchased. Customers with questions are instructed to contact their distributor directly or call the CareFusion Support Center at (888) 562-6018. If you have recall related questions or need support, please call CareFusion Support Center at 1-888-562-6018; hours: 7am to 4pm PST or Technical Support at 1-888-812-3229; hours 7am to 5pm PST.
Quantity in commerce: 480 units
Distribution: US Distribution in CA, WY, OH, UT, and MA.
Product codes and lots: Lot No: 13046215 13046641 13056285 13056577 13075931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0450-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0450-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

Product code FPA

K944320Class IIVented/non-Vented Gemini Administration SetImed Corp. / cleared 1995-02-14

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)