BEUDAMED
    FDA Recall Terminated

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    Recall: Z-1700-2015 · Initiated May 5, 2015

    Recall

    Recall Number
    Z-1700-2015
    Event Number
    71169
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 5, 2015
    Posted
    June 2, 2015
    Terminated
    October 17, 2016
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    Reason

    The product failed to meet the internal established statistical test requirement for heparin activity.

    Action

    On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838

    Distribution

    Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

    Quantity

    978