BEUDAMED
    FDA Recall Terminated

    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

    Recall: Z-2776-2015 · Initiated July 31, 2015

    Recall

    Recall Number
    Z-2776-2015
    Event Number
    71971
    Firm
    Edward Lifesciences, Llc
    FEI Number
    2015691
    Product Code
    DXO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 31, 2015
    Posted
    September 16, 2015
    Terminated
    July 8, 2016
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

    Reason

    Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

    Action

    Edwards sent an Urgent Product Recall Letter on August 10, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm's letter requests that customers return any of the units that they currently have in inventory. The letter requests that customers verify the inventory that has been pre-populated on the acknowledgment form, and complete the remainder of the form. The firm states to fax back the acknowledgment form within three days of receipt of notification to Edwards Customer Service at 1-800-422-9329. The firm requests to call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the implicated lots as well as to obtain information about product replacment. The notification states to call for an RGA prior to returning any unused product and return unused product to the firm at Edwards Lifesciences Return Goods. Any questions the firm states to contact Edwards Customer Service at 1-800-424-3278.

    Distribution

    Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.

    Quantity

    13,077 (U.S.) and 12,306 (International)