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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67128

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

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Event summary

Timeline bucket
December 06, 2013
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.

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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

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.

Z-0614-2014
Recall number
Z-0614-2014
Initiated
December 06, 2013
Classification
Class II
Status
Terminated
Quantity
59

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Inspect official wording and provenance

Reason for recall

Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

Code information

Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada.