BEUDAMED
    FDA Recall Terminated

    eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.

    Recall: Z-2880-2011 · Initiated June 22, 2011

    Recall

    Recall Number
    Z-2880-2011
    Event Number
    59178
    Firm
    eSwallow USA LLC
    FEI Number
    3007838104
    Product Code
    IPF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2011
    Posted
    July 25, 2011
    Terminated
    July 3, 2012
    Address
    106 Hidden Drive, Scottsboro, AL, 35769-9322

    Description

    eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.

    Reason

    It was discovered that the firm was distributing medical devices without FDA approval.

    Action

    eSwallow USA LLC sent an URGENT MEDICAL DEVICE RECALL letter dated June 22 2011, via US mail and email notification to each distributors. The letter identified the product, the problem, and the action to be taken. Distributors were instructed to immediately examine inventory, quarantine all product subject to recall, and identify customers that received these products and notify them at once of the recall. The letter advised distributors to forward a copy of the recall notification letter to their customers. The letter states that the distributors are to return all inventories to the eSwallow Corporate Office eSWALLOWusa, 106 Hidden Drive, Scottsboro, Al 35769. The recall should be carried out to the customer/user level. Customers are instructed to complete and return the attached Response Form as soon as possible. If you have any questions, call (256) 571-0443.

    Distribution

    Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA.

    Quantity

    123 units