BEUDAMED
    FDA Enforcement Class II Terminated

    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.

    Recall: Z-2162-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2162-2017
    Event ID
    76465
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CORPAK MedSystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    February 3, 2017
    Classification Date
    May 24, 2017
    Termination Date
    August 5, 2019
    Address
    1001 Asbury Dr, Buffalo Grove, IL, 60089-4528, United States

    Description

    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.

    Reason

    Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

    Code Info

    Catalogue Numbers: 50-6116

    Distribution

    Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand

    Quantity

    2 cases (5 units per case)