BEUDAMED
    FDA Recall Terminated

    KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.

    Recall: Z-0938-2012 · Initiated December 21, 2011

    Recall

    Recall Number
    Z-0938-2012
    Event Number
    60900
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 21, 2011
    Posted
    February 2, 2012
    Terminated
    July 2, 2012
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.

    Reason

    The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port.

    Action

    Kimberly-Clark Health Care sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter and e-mail to all affected customers. The communications described the product, problem, and actions to be taken by the customers. Customers were instructed to locate and quarantine any affected product. A Product Recall Response Sheet was enclosed for customers to complete and return to the firm via fax at 920-380-6682. Contact the firm at 770-587-7400 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CA, CO, ID, IL, MD, MO, NC, NJ, NY, PA, SC, UT, VA, WA, WI, and WV and the country of Canada.

    Quantity

    50 devices