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

Recall date

April 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1599-2015

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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