Medical device recalls Moderate risk

B. Braun Medical, Inc. recalls WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units pe…

Recall date
April 26, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1703-2016
FDA classification
Class II
Brand / firm
B. Braun Medical, Inc.
Sold / distributed
Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

Why it was recalled

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

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

What was recalled

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

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