BEUDAMED
    FDA Recall Terminated

    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

    Recall: Z-2212-2016 · Initiated July 1, 2016

    Recall

    Recall Number
    Z-2212-2016
    Event Number
    74465
    Firm
    Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
    FEI Number
    3008002452
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    July 1, 2016
    Posted
    July 22, 2016
    Terminated
    March 29, 2017

    Description

    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

    Reason

    BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs

    Action

    BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: [email protected].

    Distribution

    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.

    Quantity

    10