BEUDAMED
    FDA Enforcement Class II Terminated

    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.

    Recall: Z-2705-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2705-2016
    Event ID
    74190
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Vision Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    May 10, 2016
    Classification Date
    August 30, 2016
    Termination Date
    September 18, 2017
    Address
    Haestholmsvaegen 32, N/A, Nacka, N/A, N/A, Sweden

    Description

    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.

    Reason

    Sterility of device may be compromised due to sterile package breakage.

    Code Info

    All lot numbers of Double Pump RF Patient Cassettes delivered to the US, Batch numbers: 13I03, 14A01, 14A06, 14A09, 14A10, 14B03, 14B09, 14C06, 14C10, 14D07, 14D11, 14E06, 14E10, 14F01, 14F02, 14F03, 14F04, 14F10, 14F11, 14G07, 14H02, 14H04, 14H08, 14H09, 14J01, 14J02, and 14J03.

    Distribution

    Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.

    Quantity

    3,295 devices