BEUDAMED
    FDA Recall Terminated

    EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

    Recall: Z-2112-2009 · Initiated December 18, 2008

    Recall

    Recall Number
    Z-2112-2009
    Event Number
    50687
    Firm
    Zevex International, Inc.
    FEI Number
    1000117172
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    December 18, 2008
    Posted
    September 21, 2009
    Terminated
    October 27, 2011
    Address
    4314 Zevex Park Ln, Salt Lake City, UT, 84123

    Description

    EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

    Reason

    Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.

    Action

    All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or [email protected]. Distributors were to contact their customers and notify them of the letter.

    Distribution

    Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.

    Quantity

    32,545