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Recall Observatory FDA recall evidence

Device product

Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No

Z-1425-2025

January 31, 2025

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 96321
Status
Ongoing
Classification
Class II
Quantity
500 kits
Official record key
device-enforcement:Z-1425-2025

Official wording

Reason: Sterility assurance with procedure trays

Code information: Lot Code: UDI-DI: 00191072233776; Lot: 9219420; 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