Reported May 20, 2015 · Terminated
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published SP-101Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075. VS-301Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160 VS-402Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272. - Amount recalled
- 1661 units
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.
This product could cause temporary or reversible health problems — stop using it.
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