FDA-Device2025-03-26Class II
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc
Hazard
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.
Sold states
US: MI
Affected count
91 units
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2025Don't want to check this manually?
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