BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1599-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1599-2015
    Event ID
    71138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    April 28, 2015
    Classification Date
    May 12, 2015
    Termination Date
    March 29, 2016
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    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.

    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.

    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