BEUDAMED
    FDA Recall 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 · Initiated May 31, 2016

    Recall

    Recall Number
    Z-2239-2016
    Event Number
    74295
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 31, 2016
    Posted
    July 19, 2016
    Terminated
    May 24, 2017
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    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.

    Action

    Customers were notified of the recall via certified letter beginning on May 31, 2016. The letter requests that customers immediately inventory your supplies of the Recalled product in all appropriate areas and cease use of all affected stock. In addition, they are asked to complete the enclosed Recall Response Card indicating whether you have any of the Recalled product on hand, as well as the quantity of product that you have in stock.

    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