FDAClass IIApril 2, 2025

Brand Name: Banner Health Systems Product Name: Cysto recall: Sterility Concern

Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No

Why was Brand Name: Banner Health Systems Product Name: Cysto recalled?

Sterility assurance with procedure trays

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026

Product
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Recalling firm
American Contract Systems, Inc.
Quantity
800
Distribution
US: AZ OUS: None
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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