Exact FDA event identifier

Event 96321

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 31, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: American Contract Systems, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-1424-2025

Recall number: Z-1424-2025
Initiated: January 31, 2025
Classification: Class II
Status: Ongoing
Recalling firm: American Contract Systems, Inc.
Quantity: 800

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterility assurance with procedure trays

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance with procedure trays

Code information

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

Distribution pattern

US: AZ OUS: None

device · product 2 of 3

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

Recall number: Z-1425-2025
Initiated: January 31, 2025
Classification: Class II
Status: Ongoing
Recalling firm: American Contract Systems, Inc.
Quantity: 500 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterility assurance with procedure trays

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance with procedure trays

Code information

Lot Code: UDI-DI: 00191072233776; Lot: 9219420; Exp: 01/21/2026

Distribution pattern

US: AZ OUS: None

device · product 3 of 3

Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No

Z-1426-2025

Recall number: Z-1426-2025
Initiated: January 31, 2025
Classification: Class II
Status: Ongoing
Recalling firm: American Contract Systems, Inc.
Quantity: 460 kits.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterility assurance with procedure trays

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance with procedure trays

Code information

Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026

Distribution pattern

US: AZ OUS: None