BEUDAMED
    FDA Recall Terminated

    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.

    Recall: Z-0764-2013 · Initiated October 12, 2012

    Recall

    Recall Number
    Z-0764-2013
    Event Number
    63485
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 12, 2012
    Posted
    January 31, 2013
    Terminated
    April 10, 2014
    Address
    4314 Zevex Park Ln, Salt Lake City, UT, 84123-7881

    Description

    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.

    Reason

    The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.

    Action

    An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: [email protected].

    Distribution

    Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).

    Quantity

    92,488 units