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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83017

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

Open FDA event record

Event summary

Timeline bucket
May 23, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leventon S. A. U.

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

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

Z-2360-2019
Recall number
Z-2360-2019
Initiated
May 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Leventon S. A. U.
Quantity
1700

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

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 product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

Code information

172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

Distribution pattern

US Distribution to states in: AZ, CA, MA, MI, PR, and FL.