FDA Enforcement
Class II
Ongoing
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Recall: Z-1424-2025
·
Reported April 2, 2025
Enforcement
- Recall Number
- Z-1424-2025
- Event ID
- 96321
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 2, 2025
- Initiation Date
- January 31, 2025
- Classification Date
- March 21, 2025
- Address
- 7300 W Detroit St, N/A, Chandler, AZ, 85226-2410, United States
Description
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Reason
Sterility assurance with procedure trays
Code Info
Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026
Distribution
US: AZ OUS: None
Quantity
800