Medical device recalls Moderate risk

American Contract Systems, Inc. recalls Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenien…

Recall date
January 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1424-2025
FDA classification
Class II
Brand / firm
American Contract Systems, Inc.
Sold / distributed
US: AZ OUS: None

Why it was recalled

Sterility assurance with procedure trays

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

What was recalled

Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No

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