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

Recalled May 20, 2015 · FDA recall Z-1599-2015 · Covidien

Hazard

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

Units

1661 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Covidien LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →