BEUDAMED
    FDA Recall Terminated

    EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.

    Recall: Z-0294-2013 · Initiated November 8, 2012

    Recall

    Recall Number
    Z-0294-2013
    Event Number
    63660
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 8, 2012
    Posted
    November 15, 2012
    Terminated
    January 30, 2014
    Address
    4314 Zevex Park Ln, Salt Lake City, UT, 84123-7881

    Description

    EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.

    Reason

    MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.

    Action

    MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.

    Distribution

    Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.

    Quantity

    8,736