BEUDAMED
    FDA Recall Terminated

    MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

    Recall: Z-0367-2011 · Initiated May 17, 2010

    Recall

    Recall Number
    Z-0367-2011
    Event Number
    55839
    Firm
    Medrad Inc
    FEI Number
    3006316319
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 17, 2010
    Posted
    November 15, 2010
    Terminated
    November 17, 2010
    Address
    100 Global View Dr, Warrendale, PA, 15086

    Description

    MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

    Reason

    Some kits have a hole in the packaging which could compromise the sterility of the components.

    Action

    MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take. Customers were instructed to identify the product with the affected lot numbers. Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product. Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942. For any questions regarding this recall call (412) 767-2400, ext 6851.

    Distribution

    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore.

    Quantity

    39,448 syringe kits