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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85342

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

Open FDA event record

Event summary

Timeline bucket
September 12, 2019
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

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

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

Z-1956-2020
Recall number
Z-1956-2020
Initiated
September 12, 2019
Classification
Class II
Status
Terminated
Quantity
15 kits

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error: Due to a manufacturing

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

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

Code information

Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357

Distribution pattern

US Nationwide distribution in the state of MI.