Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or c…

Recall date
November 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0445-2016
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.

Why it was recalled

CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

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

What was recalled

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

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