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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81460

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

Open FDA event record

Event summary

Timeline bucket
October 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Numed 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

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

Z-0510-2019
Recall number
Z-0510-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
Numed Inc
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use booklets were not included on the outer pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Instructions for Use booklets were not included on the outer pouch

Code information

Lot numbers: 5MT-1264, 5MT-1265 Exp. Date: 2023-09-30 UDI: 04046964312700

Distribution pattern

US distribution in the state of PA

device · product 2 of 2

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

Z-0511-2019
Recall number
Z-0511-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
Numed Inc
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for Use booklets were not included on the outer pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Instructions for Use booklets were not included on the outer pouch

Code information

Lot numbers: 6MT-0645, 6MT-0646 Exp. Date: 2023-09-30 UDI: 04046964312861

Distribution pattern

US distribution in the state of PA