Medical device recalls Moderate risk

CareFusion 303, Inc. recalls MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer f…

Recall date
February 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1482-2017
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

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, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

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