BEUDAMED
    FDA Recall Terminated

    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.

    Recall: Z-0674-2016 · Initiated September 21, 2015

    Recall

    Recall Number
    Z-0674-2016
    Event Number
    72630
    Firm
    Valeant Pharmacueticals International
    FEI Number
    3009443653
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    September 21, 2015
    Posted
    January 21, 2016
    Terminated
    May 19, 2017
    Address
    400 Somerset Corporate Blvd, Bridgewater, NJ, 08807-2867

    Description

    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.

    Reason

    The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

    Action

    Valeant Pharmaceuticals International, Inc. sent Field Correction Notifications /Recall Stock Response Form dated September 22, 2015 through 2nd day air service to their customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. T The customers were requested to fill out and return the attached Recall Stock Response Form and return the form via email ([email protected] or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576) On October 7, 2015 a second field correction notification was sent to customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576). The updated notification clarified that the notification applies to all SPAG-2 6000 model units currently in the market.

    Distribution

    USA (nationwide) Distribution and Internationally to Canada and France.

    Quantity

    1178