| Class 2 Device Recall VenaSeal Closure System |  |
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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = PJQ
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