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U.S. Department of Health and Human Services

Class 2 Device Recall VenaSeal Closure System

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  Class 2 Device Recall VenaSeal Closure System see related information
Date Initiated by Firm April 28, 2015
Date Posted May 12, 2015
Recall Status1 Terminated 3 on March 29, 2016
Recall Number Z-1599-2015
Recall Event ID 71138
PMA Number P140018 
Product Classification Agent, occluding, vascular, permanent - Product Code PJQ
Product VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Code Information 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.
Recalling Firm/
Manufacturer		 Covidien LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Carlos Alfonzo
508-261-8000
Manufacturer Reason
for Recall		 Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
FDA Determined
Cause 2		 Package design/selection
Action Consignees were contacted by letter via email on April 28, 2015.
Quantity in Commerce 1661 units
Distribution Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = PJQ and Original Applicant = MEDTRONIC VASCULAR INC
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