BEUDAMED
    FDA Recall Terminated

    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    Recall: Z-0831-2018 · Initiated October 19, 2017

    Recall

    Recall Number
    Z-0831-2018
    Event Number
    79192
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 19, 2017
    Terminated
    April 16, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    Reason

    Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

    Action

    On October 19, 2017 an URGENT MEDICAL DEVICE RECALL letter was mailed to customers requesting that they examine inventory for affected product, immediately quarantine and return product to recalling firm for credit. Questions or concerns can be directed to 1-800-457-4500 or 812-330-2235.

    Distribution

    US Nationwide Distribution

    Quantity

    Quantities co-mingled into line 1