FDA-Device2015-05-20Class II
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Covidien LLC
Hazard
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Sold states
Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
Affected count
1661 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1599-2015Don't want to check this manually?
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