PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 2, 2025 Initiated: January 31, 2025 #Z-1426-2025

Product Description

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

Details

Units Affected
460 kits.
Distribution
US: AZ OUS: None
Location
Chandler, AZ

Frequently Asked Questions

What product was recalled?
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. Recalled by American Contract Systems, Inc.. Units affected: 460 kits..
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-1426-2025.