Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenienc

FDA device recall Z-1424-2025 · posted 2025-03-21 · Open, Classified

Recall details

Recalling firm

American Contract Systems, Inc.

Reason for recall

Sterility assurance with procedure trays

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

NWU

Quantity affected

800

Distribution

US: AZ OUS: None

Date initiated

2025-01-31

Date posted

2025-03-21

Location

Chandler, AZ