BEUDAMED
    FDA Enforcement Class II Ongoing

    Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

    Recall: Z-0482-2022 · Reported January 19, 2022

    Enforcement

    Recall Number
    Z-0482-2022
    Event ID
    88984
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ohio Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 19, 2022
    Initiation Date
    November 16, 2021
    Classification Date
    January 11, 2022
    Address
    1111 Lakeside Dr, N/A, Gurnee, IL, 60031-2489, United States

    Description

    Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

    Reason

    Increase in premature device failures

    Code Info

    Shipped between March 2019 and February 2021.

    Distribution

    US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.

    Quantity

    649 portable suction pumps and replacement pumps