BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.

    Recall: Z-0415-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0415-2016
    Event ID
    72682
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MOOG Medical Devices Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2015
    Initiation Date
    November 20, 2015
    Classification Date
    December 14, 2015
    Termination Date
    August 22, 2016
    Address
    4314 S Zevex Park Ln, N/A, Salt Lake City, UT, 84123-7881, United States

    Description

    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.

    Reason

    Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.

    Code Info

    All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.

    Distribution

    Distributed to the state of MN.

    Quantity

    12,014,130 sets