Z-1424-2025 Class II Ongoing
FDA device recall Z-1424-2025 was initiated by American Contract Systems, Inc. on January 31, 2025 and is designated Class II. Reason for recall: Sterility assurance with procedure trays The recall status is ongoing. Affected quantity: 800.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- January 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800
Product Description
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 Pattern
US: AZ OUS: None
Code Information
Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026