BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1599-2015 · Initiated April 28, 2015

    Recall

    Recall Number
    Z-1599-2015
    Event Number
    71138
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    PJQ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 28, 2015
    Posted
    May 12, 2015
    Terminated
    March 29, 2016
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

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

    Reason

    Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.

    Action

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

    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.

    Quantity

    1661 units