Recall Z-0450-2014— CareFusion 303, Inc.

Name: FDA recall Z-0450-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-08

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2013-11-08, terminated 2014-05-27. It names one FDA 510(k) clearance: K944320. 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: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Terminated: 2014-05-27
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SETImed Corp.·cleared 1995-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.