American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

Recall date

February 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1406-2025

FDA classification

Class II

Brand / firm

American Contract Systems Inc

Sold / distributed

US: MI

Why it was recalled

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

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

What was recalled

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.