BEUDAMED
    FDA Enforcement Class II Terminated

    Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    Recall: Z-0830-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0830-2018
    Event ID
    79192
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    October 19, 2017
    Classification Date
    March 1, 2018
    Termination Date
    April 16, 2019
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Mallinckrodt Institute Percutaneous Gastrostomy 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.

    Code Info

    WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495

    Distribution

    US Nationwide Distribution

    Quantity

    615