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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91077

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

Open FDA event record

Event summary

Timeline bucket
October 12, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

BASIN SET, MEBS42K, general surgical kit

Z-0274-2023
Recall number
Z-0274-2023
Initiated
October 12, 2022
Classification
Class II
Status
Terminated
Quantity
1504 trays

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.

Code information

UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023

Distribution pattern

US Nationwide distribution.