Z-1424-2025Class II

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

Name: Z-1424-2025 Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description...
Creator: American Contract Systems, Inc.
Published: 2025-01-31
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-01-31 / Open, Classified / root cause: sterility

FDA source

American Contract Systems, Inc. began a recall of Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No on 2025-01-31. FDA classified it as Class II and gives the reason as "Sterility assurance with procedure trays". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1424-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-03-21
Recalling firm: American Contract Systems, Inc.
Product: Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Product code: NWU Endoscope Introducer Kit
Reason for recall: Sterility assurance with procedure trays
Root cause tag: sterility
FDA 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 in commerce: 800
Distribution: US: AZ OUS: None
Product codes and lots: Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1424-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1424-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21
Z-1425-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21
Z-1426-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

Product code NWU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)