BEUDAMED
    FDA Recall Terminated

    Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.

    Recall: Z-1725-2011 · Initiated March 8, 2011

    Recall

    Recall Number
    Z-1725-2011
    Event Number
    58123
    Firm
    Millar Instruments, Inc
    FEI Number
    1625382
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 8, 2011
    Posted
    March 24, 2011
    Terminated
    June 27, 2011
    Address
    6001-A Gulf Fwy, Houston, TX, 77023

    Description

    Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.

    Reason

    Possibility of epoxy debris particles inside the catheter lumen.

    Action

    The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.

    Distribution

    MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.

    Quantity

    1080 units