PlainRecalls
FDA Devices Moderate Class II Ongoing

Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No

Reported: April 2, 2025 Initiated: January 31, 2025 #Z-1424-2025

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

Details

Units Affected
800
Distribution
US: AZ OUS: None
Location
Chandler, AZ

Frequently Asked Questions

What product was recalled?
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No. Recalled by American Contract Systems, Inc.. Units affected: 800.
Why was this product recalled?
Sterility assurance with procedure trays
Which agency issued this recall?
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1424-2025.