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Terminated

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

FDA Recall Z-1599-2015 · Posted 2015-05-12

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodePJQ
Date Initiated2015-04-28
Date Terminated2016-03-29
Product Quantity1661 units

Reason for Recall

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

Firm Action

Consignees were contacted by letter via email on April 28, 2015.

Root Cause

Package design/selection

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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