American Contract Systems, Inc.: Device Recall

Recall #Z-1426-2025 · 01/31/2025

Class II: Risk

Recall Details

Recall Number: Z-1426-2025
Classification: Class II
Product Type: Device
Recalling Firm: American Contract Systems, Inc.
Status: Ongoing
Date Initiated: 01/31/2025
Location: Chandler, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 460 kits.

Reason for Recall

Sterility assurance with procedure trays

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

Distribution Pattern

US: AZ OUS: None

Other Recalls by American Contract Systems, Inc.

Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

View all recalls by American Contract Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.