Exact FDA event identifier

Event 65245

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

Open FDA event record

Event summary

Timeline bucket: May 29, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: IDEV Technologies, 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

IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

Z-1550-2013

Recall number: Z-1550-2013
Initiated: May 29, 2012
Classification: Class II
Status: Terminated
Recalling firm: IDEV Technologies, Inc.
Quantity: 3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There was an error on the outer labeling of this device. The inner label was correct.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There was an error on the outer labeling of this device. The inner label was correct.

Code information

Model Number: S-05-100-120-G3; Lot Number 01049037

Distribution pattern

Nationwide Distribution to the states of FL, NY, and PA.