BEUDAMED
    FDA Recall Terminated

    Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051

    Recall: Z-0292-2008 · Initiated October 25, 2007

    Recall

    Recall Number
    Z-0292-2008
    Event Number
    45817
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 25, 2007
    Posted
    December 11, 2007
    Terminated
    April 22, 2008
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051

    Reason

    Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised

    Action

    The recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.

    Distribution

    Worldwide-USA and countries of Germany, Israel, Finalnd, Italy, Netherland, Austria, France, Japan, Denmark, Ireland, South Africia, Australia, Saudi Arabia, Singapore, Canada, New Zealand, Spain, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.

    Quantity

    25, 977 units