BEUDAMED
    FDA Recall Terminated

    Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.

    Recall: Z-2305-2008 · Initiated June 27, 2008

    Recall

    Recall Number
    Z-2305-2008
    Event Number
    48725
    Firm
    Abbott Laboratories
    FEI Number
    1513768
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 27, 2008
    Posted
    September 20, 2008
    Terminated
    September 19, 2012
    Address
    625 Cleveland Ave, Columbus, OH, 43215-1754

    Description

    Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.

    Reason

    Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."

    Action

    On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance.

    Distribution

    Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY.

    Quantity

    57,120 units