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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71138

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

Open FDA event record

Event summary

Timeline bucket
April 28, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien LLC

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

VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.

Z-1599-2015
Recall number
Z-1599-2015
Initiated
April 28, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1661 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach of the outer packaging (pouch) material which may compromise

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.

Code information

Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272.

Distribution pattern

Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.