BEUDAMED
    FDA Recall Terminated

    ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)

    Recall: Z-0359-2008 · Initiated October 3, 2007

    Recall

    Recall Number
    Z-0359-2008
    Event Number
    45465
    Firm
    Acist Medical Systems
    FEI Number
    3001726808
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 3, 2007
    Posted
    December 8, 2007
    Terminated
    October 6, 2008
    Address
    7450 Flying Cloud Dr, Ste 150, Eden Prairie, MN, 55344-3720

    Description

    ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)

    Reason

    Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.

    Action

    The Urgent Medical Device Recall letter was sent by certified mail to all U.S. base customers on 10/3,4/07. Customers were advised to stop distribution of the product and immediately cease use of the product. Recalled product is to be returned using the FedEx Airbill that was enclosed with the recall letter. Customers were to complete the enclosed "Device Recall Response" form even if they did not have any impacted kits in inventory.

    Distribution

    Nationwide Distribution - including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

    Quantity

    177,050 Kits