BEUDAMED
    FDA Recall 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 · Initiated November 20, 2015

    Recall

    Recall Number
    Z-0415-2016
    Event Number
    72682
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    PIF
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 20, 2015
    Terminated
    August 22, 2016
    Address
    4314 S Zevex Park Ln, Salt Lake City, UT, 84123-7881

    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.

    Action

    MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or [email protected].

    Distribution

    Distributed to the state of MN.

    Quantity

    12,014,130 sets