BEUDAMED
    FDA Recall Terminated

    Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700

    Recall: Z-0609-03 · Initiated January 27, 2003

    Recall

    Recall Number
    Z-0609-03
    Event Number
    25470
    Firm
    Novartis Nutrition Corp
    FEI Number
    2110851
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2003
    Posted
    March 5, 2003
    Terminated
    June 24, 2004
    Address
    1541 Park Place Blvd, St Louis Park, MN, 55416

    Description

    Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700

    Reason

    Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.

    Action

    The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.

    Distribution

    Nationwide in the United States and to Canada

    Quantity

    11 cases (30 tube sets per case)