Medical device recalls Moderate risk

Merit Medical Systems, Inc. recalls Manifold Kit. Catalog Number K09-11867AP

Recall date
September 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0632-2017
FDA classification
Class II
Brand / firm
Merit Medical Systems, Inc.
Sold / distributed
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.

Why it was recalled

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

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

What was recalled

Manifold Kit. Catalog Number K09-11867AP

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