BEUDAMED
    FDA Enforcement Class II Terminated

    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.

    Recall: Z-2410-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2410-2018
    Event ID
    80294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ohio Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 18, 2018
    Initiation Date
    March 12, 2018
    Classification Date
    July 10, 2018
    Termination Date
    July 16, 2020
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031-2489, United States

    Description

    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.

    Reason

    Final quality control testing was not completed before the devices were distributed..

    Code Info

    UDI 08688250002085; Catalog Numbers 8702-1251-908, 8701-1251-901, 8705-1251-907, 8701-1251-908, 8705-1251-901; Lot Number ISU177359; Device Unit Numbers JGGW24156, JGGW24193, JGGW24157, JGGW24161 ,JGGW24167, JGGW24169, JGGW24175, JGGW24188, JGGW24189, JGGW24198, JGGW24160

    Distribution

    US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.

    Quantity

    11 units