BEUDAMED
    FDA Enforcement Class II Terminated

    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

    Recall: Z-2239-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2239-2016
    Event ID
    74295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    May 31, 2016
    Classification Date
    July 19, 2016
    Termination Date
    May 24, 2017
    Address
    250 Campus Dr, N/A, Marlborough, MA, 01752-3020, United States

    Description

    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

    Reason

    Cracks ATEC Canister Lids.

    Code Info

    Lot Number: 20150013 and 20150014

    Distribution

    Worldwide distribution. US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, and South Africa.

    Quantity

    16,870