BEUDAMED
    FDA Recall Terminated

    Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator

    Recall: Z-0717-2012 · Initiated October 19, 2011

    Recall

    Recall Number
    Z-0717-2012
    Event Number
    60767
    Firm
    Impact Instrumentation, Inc.
    FEI Number
    1220908
    Product Code
    CAI
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    October 19, 2011
    Posted
    January 12, 2012
    Terminated
    March 11, 2013
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206

    Description

    Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator

    Reason

    Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).

    Action

    Impact sent Urgent Device Product Recall letters/return response forms dated 10/19/11 to their consignees. The letter asked customers to return the affected product listed to the address provided within 10 days of receipt of the notification letter. In order to receive proper credit for the returned product, customers should follow the instructions precisely, which includes completing and returning the Recall Tracking Form along with the affected product. If customers have no product to return, they should contact Alan Giordano at [email protected], to inform him of the status of the circuits.

    Distribution

    Nationwide Distribution -- VA, CA, IL, NC, and TX.

    Quantity

    564 units