Class II
Medical Device Recall: CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc · February 4, 2025
Reason for Recall
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.
Distribution
US: MI
States Affected
MI
Quantity Affected
91 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1406-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.