BEUDAMED
    FDA Recall Terminated

    ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    Recall: Z-2406-2008 · Initiated June 6, 2008

    Recall

    Recall Number
    Z-2406-2008
    Event Number
    49075
    Firm
    Acist Medical Systems
    FEI Number
    3001726808
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 6, 2008
    Posted
    September 23, 2008
    Terminated
    January 25, 2011
    Address
    7905 Fuller Road, Eden Prairie, MN, 55344

    Description

    ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    Reason

    Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.

    Action

    Consignees were sent a "Urgent: Medical Device Recall" letter dated July 9. 2008. The letter addressed to "Manager" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.

    Distribution

    Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.

    Quantity

    11,750 (USA), 22,230 (OUS)