Data Foundry

Medical device recalls 2013

SmartSite Low Sorbing Infusion Set with Texium Close Male Luer — Class II medical device recall Z-0450-2014

Terminated recall by CareFusion 303, Inc., reported 2013-12-11, distributed in CA, MA, OH, UT, WY. CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not

Recall numberZ-0450-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2013-11-08
Classified2013-12-04
Reported by FDA2013-12-11
Terminated2014-05-27
DistributedCA, MA, OH, UT, WY
Quantity480 units
Lot numbers13046215, 13046641, 13056285, 13056577, 13075931
Model numbers24301-0007T

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0450-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.