BEUDAMED
    FDA Recall Terminated

    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

    Recall: Z-0566-2022 · Initiated December 22, 2021

    Recall

    Recall Number
    Z-0566-2022
    Event Number
    89290
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 22, 2021
    Terminated
    August 15, 2023
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

    Reason

    The External Retention Bolster contained in the kit may be a larger diameter than the tube.

    Action

    All USA Distributors and healthcare facilities that were directly shipped impacted devices were sent a Product Advisory Notice beginning on December 22, 2021 by email. Clinical Consignees were instructed to evaluate their facilities inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and return impacted product. The clinician may recognize that the External Retention Bolster is too large for the accompanying PEG tube when initially use the product. Consignees were instructed to complete an Acknowledgement Form and return a copy of the form to Avanos within five (5) days.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Chile.

    Quantity

    692 units