FDA Medical devices recall ·
Banner Health Systems Product Name: Cysto Pack Model recall
- Recall number
- Z-1424-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- American Contract Systems Inc
7300 W Detroit St, Chandler, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 800
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Why was it recalled?
Sterility assurance with procedure trays
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026
Distribution
US: AZ OUS: None
States: Arizona
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1424-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.