BEUDAMED
    FDA Recall 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 · Initiated February 3, 2017

    Recall

    Recall Number
    Z-2162-2017
    Event Number
    76465
    Firm
    CORPAK MedSystems, Inc.
    FEI Number
    3011270181
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 3, 2017
    Terminated
    August 5, 2019
    Address
    1001 Asbury Dr, Buffalo Grove, IL, 60089-4528

    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.

    Action

    Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.

    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)