CareFusion 303, Inc. recalls SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and med…

Recall date

January 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1053-2015

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.