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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63857

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

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Event summary

Timeline bucket
December 10, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arjo, Inc. dba ArjoHuntleigh

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

Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.

Z-0615-2013
Recall number
Z-0615-2013
Initiated
December 10, 2012
Classification
Class II
Status
Terminated
Quantity
2,859 unts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

Code information

Model 512003, all serial numbers

Distribution pattern

USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.

Field note

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