BEUDAMED
    FDA Enforcement Class II Terminated

    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

    Recall: Z-1849-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1849-2016
    Event ID
    73427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    March 3, 2016
    Classification Date
    May 31, 2016
    Termination Date
    June 15, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

    Reason

    Compromised sterility due to breach of barrier

    Code Info

    All lots beginning with 110000233562 through lot 120002651262X

    Distribution

    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

    Quantity

    2418560