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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91829

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

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Event summary

Timeline bucket
February 20, 2023
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mani, Inc. - Kiyohara 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

Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

Z-1468-2023
Recall number
Z-1468-2023
Initiated
February 20, 2023
Classification
Class II
Status
Terminated
Quantity
45 kits

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
packaging defect may compromise the sterile

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

A packaging defect may compromise the sterile barrier.

Code information

UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)

Distribution pattern

Distribution in US - 1 consignee in Missouri