FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: 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
- Recall number
- Z-1426-2025
- Recalling firm
- American Contract Systems, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-01-31
- Posted
- 2025-03-21
- Terminated
- not on file
- Reason
- Sterility assurance with procedure trays
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 460 kits.
- Distribution
- US: AZ OUS: None
- Lot, serial or model codes
- Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OES
- Firm FEI
- 3010126341
- Firm city
- Chandler
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28