—#212577

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

FDA product code: OES — Cardiac Catheterization Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026

Why it was recalled

Sterility assurance with procedure trays

Root cause (FDA determination)

Process change control

Action the firm took

On 1/31/25 customers were notified via. phone about the recall. On February 11, 2025, Owens & Minor, the parent company of American Contract System issued a "Urgent: Medical Device Recall" notification via email to affected customers. 1. DISCONTINUE USE of the procedure trays listed in Table 1 above. 2. RETURN PRODUCT: Contact your ACS Sales Representative for instructions on returning all product to ACS. 3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this recall and all unused product is returned, and maintain records of effectiveness. 4. Complete the attached Recall Response Form and return as soon as possible.

Recalling firm

Firm: American Contract Systems, Inc.
Address: 7300 W Detroit St, Chandler, Arizona 85226-2410

Distribution

Distribution pattern: US: AZ OUS: None

Timeline

Recall initiated: 2025-01-31
Posted by FDA: 2025-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.