Recall Z-1426-2025— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2025-01-31. FDA's recall record names no specific 510(k) clearance for this event. 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: Sterility assurance with procedure trays.
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-31
- Firm location
- Chandler, AZ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.