BEUDAMED
    FDA Recall Terminated

    MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.

    Recall: Z-1228-2009 · Initiated January 29, 2009

    Recall

    Recall Number
    Z-1228-2009
    Event Number
    51495
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 29, 2009
    Posted
    June 1, 2009
    Terminated
    June 4, 2009
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.

    Reason

    Possible compromised sterility due to holes in styrene tray

    Action

    On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09.

    Distribution

    Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.

    Quantity

    2958 kits