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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90763

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 10, 2022
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Steris Corporation Hopkins Facility

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

1 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 1

Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

Z-1736-2022
Recall number
Z-1736-2022
Initiated
August 10, 2022
Classification
Class III
Status
Terminated
Quantity
619 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product contains incorrect chemical indicators in packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product contains incorrect chemical indicators in packaging.

Code information

UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A

Distribution pattern

Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY