FDA recall Z-1426-2025

American Contract Systems, Inc. · Class II · device

Product

Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A 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-1426-2025