Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1424-2025

January 31, 2025

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 96321
Status
Ongoing
Classification
Class II
Quantity
800
Official record key
device-enforcement:Z-1424-2025

Official wording

Reason: Sterility assurance with procedure trays

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

Distribution pattern: US: AZ OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility assurance with procedure trays