FDA recall Z-1424-2025
American Contract Systems, Inc. · Class II · device
Product
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Reason for recall
Sterility assurance with procedure trays
Distribution
US: AZ OUS: None
Key facts
- Status
- Ongoing
- Initiation date
- 2025-01-31
- Report date
- 2025-04-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Chandler, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1424-2025