BEUDAMED
    FDA Recall 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 · Initiated October 24, 2018

    Recall

    Recall Number
    Z-0526-2019
    Event Number
    81452
    Firm
    Neomed Inc
    FEI Number
    3011270181
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 24, 2018
    Terminated
    September 16, 2020
    Address
    100 Londonderry Ct, Ste 112, Woodstock, GA, 30188-7353

    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

    Action

    The firm, NeoMed, sent an URGENT: MEDICAL DEVICE RECALL" letter dated 10/24/2018 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Please contact NeoMed Quality Assurance by email to [email protected] to confirm receipt of this letter and obtain a Return Materials Authorization for any units identified above that remain in your inventory. Or, you may mail the enclosed reply card to NeoMed Inc., 100 Londonderry Ct #112, Woodstock, GA 30188. If you have any questions, call 770-516-2225 or email: [email protected].

    Distribution

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

    Quantity

    654 boxes (32700 units)