Medical device recalls Moderate risk

CareFusion 303, Inc. recalls SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter insert…

Recall date
October 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0221-2016
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
Distributed US (nationwide) and in Canada.

Why it was recalled

CareFusion is recalling the SmartSite Extension 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 Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

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