Class II
Medical Device Recall: 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
American Contract Systems, Inc. · January 31, 2025
Reason for Recall
Sterility assurance with procedure trays
Distribution
US: AZ OUS: None
States Affected
AZ
Quantity Affected
460 kits.
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1426-2025
Status: ongoing
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