Medical device recalls Moderate risk

Creganna Medical Devices recalls Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2530-2017
FDA classification
Class II
Brand / firm
Creganna Medical Devices
Sold / distributed
Distributed in MA.

Why it was recalled

Lack of sterility assurance.

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

What was recalled

Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100

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