BEUDAMED
    FDA Recall Terminated

    MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand

    Recall: Z-1435-06 · Initiated July 21, 2006

    Recall

    Recall Number
    Z-1435-06
    Event Number
    35964
    Firm
    Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands
    FEI Number
    3005121848
    Product Code
    FSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2006
    Posted
    August 23, 2006
    Terminated
    November 15, 2006

    Description

    MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand

    Reason

    Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier

    Action

    The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.

    Distribution

    World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.

    Quantity

    540 caps