Medical device recalls Moderate risk

CareFusion 303, Inc. recalls MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

Recall date
February 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1464-2017
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
US Distribution including MA and MD

Why it was recalled

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

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

What was recalled

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

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