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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71305

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

Open FDA event record

Event summary

Timeline bucket
May 15, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vascutek, Ltd.

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

Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.

Z-1912-2015
Recall number
Z-1912-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
Vascutek, Ltd.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Code information

Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191

Distribution pattern

Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.

device · product 2 of 2

Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.

Z-1913-2015
Recall number
Z-1913-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
Vascutek, Ltd.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Code information

Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215

Distribution pattern

Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.