BEUDAMED
    FDA Enforcement Class III Terminated

    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

    Recall: Z-0526-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0526-2019
    Event ID
    81452
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neomed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    October 24, 2018
    Classification Date
    November 30, 2018
    Termination Date
    September 16, 2020
    Address
    100 Londonderry Ct Ste 112, N/A, Woodstock, GA, 30188-7353, United States

    Description

    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

    Reason

    The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date

    Code Info

    (UDIs) on the shipper [(01)20817584012015 (17)191109 (10)20161110], case [(01)10817584012018 (17)1991109 (10)20161110] and pouch [(01)00817584012011 (17)191109 (10)20161110] Lot Number: 20161110

    Distribution

    US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.

    Quantity

    654 boxes (32700 units)