—#136202

Product

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

FDA product code: PJQ — Agent, Occluding, Vascular, Permanent
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P140018
Affected lot / code info: Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272.

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

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.

Timeline

Recall initiated: 2015-04-28
Posted by FDA: 2015-05-12
Terminated: 2016-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.