BEUDAMED
    FDA Recall Terminated

    ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.

    Recall: Z-1043-05 · Initiated July 12, 2005

    Recall

    Recall Number
    Z-1043-05
    Event Number
    32688
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    GEA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2005
    Posted
    July 22, 2005
    Terminated
    July 24, 2006
    Address
    680 Vaqueros Ave, Sunnyvale, CA, 94085-3523

    Description

    ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.

    Reason

    Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection

    Action

    The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.

    Distribution

    The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi Arabia, the UK, Egypt, Italy, and Australia, as well as 12 medical facilities in New Jersey, New York, Ohio, Maryland, Montana, Oregon, Illinois, Washington, Wisconsin and Nevada. Dates of distribution and manufacture are approximations, provided by the recalling firm.

    Quantity

    500 units, 180 in the U.S., 320 aborad