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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83738

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

Open FDA event record

Event summary

Timeline bucket
October 26, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merit Medical 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

2 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 2

Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409

Z-0026-2020
Recall number
Z-0026-2020
Initiated
October 26, 2018
Classification
Class II
Status
Terminated
Quantity
88 Kits

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

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Code information

Catalog #K12T-03688H - Lot #T1401193 and #T1419935

Distribution pattern

U.S.: VA, IL

device · product 2 of 2

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Z-0027-2020
Recall number
Z-0027-2020
Initiated
October 26, 2018
Classification
Class II
Status
Terminated
Quantity
24 kits

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

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Code information

Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Distribution pattern

U.S.: VA, IL