BEUDAMED
    FDA Recall Terminated

    Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit.

    Recall: Z-1184-2007 · Initiated June 26, 2007

    Recall

    Recall Number
    Z-1184-2007
    Event Number
    38409
    Firm
    Arizant Healthcare, Inc
    FEI Number
    2183725
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2007
    Posted
    August 18, 2007
    Terminated
    March 2, 2008
    Address
    10393 W 70th St, Eden Prairie, MN, 55344-3446

    Description

    Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit.

    Reason

    Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.

    Action

    All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.

    Distribution

    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.

    Quantity

    12,000