BEUDAMED
    FDA Recall Terminated

    Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090

    Recall: Z-0001-06 · Initiated September 13, 2005

    Recall

    Recall Number
    Z-0001-06
    Event Number
    33407
    Firm
    VIASYS Med Systems
    FEI Number
    3011270181
    Product Code
    FXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 13, 2005
    Posted
    October 4, 2005
    Terminated
    December 30, 2005
    Address
    100 Chaddick Dr, Wheeling, IL, 60090-6006

    Description

    Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090

    Reason

    The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

    Action

    VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.

    Distribution

    Nationwide and internationally to Japan, Chile and Switzerland

    Quantity

    481 cases