BEUDAMED
    FDA Recall Terminated

    Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.

    Recall: Z-1828-2008 · Initiated April 14, 2008

    Recall

    Recall Number
    Z-1828-2008
    Event Number
    47889
    Firm
    Mallinckrodt Inc
    FEI Number
    1518293
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 14, 2008
    Posted
    September 3, 2008
    Terminated
    May 20, 2011
    Address
    2111 E Galbraith Rd, Cincinnati, OH, 45237-1624

    Description

    Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.

    Reason

    The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

    Action

    Letter dated April 18, 2008. The firm has requested their customers check their inventory, and determine if they have any of the affected suspension systems. If they observe any loose screws or cracking around the J-Bow tube, immediately take the system out of service. A service representative will contact them to schedule any required system corrections. For assistance, contact Product Monitoring Department at 1-800-778-7898 or by email at [email protected].

    Distribution

    Product was sold in 46 US states: 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV & WY,

    Quantity

    2546 pieces