BEUDAMED
    FDA Recall Terminated

    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.

    Recall: Z-1922-2013 · Initiated July 24, 2013

    Recall

    Recall Number
    Z-1922-2013
    Event Number
    65781
    Firm
    Nestle HealthCare Nutrition
    FEI Number
    2110851
    Product Code
    FPD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 24, 2013
    Posted
    August 6, 2013
    Terminated
    June 13, 2014
    Address
    12500 Whitewater Dr, Minnetonka, MN, 55343-9420

    Description

    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.

    Reason

    Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.

    Action

    Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.

    Distribution

    US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.

    Quantity

    37,310