BEUDAMED
    FDA Recall Terminated

    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

    Recall: Z-1689-2015 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1689-2015
    Event Number
    70681
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2015
    Posted
    May 28, 2015
    Terminated
    January 18, 2019
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

    Reason

    A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

    Action

    Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to [email protected]. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia Montenegro, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and Uruguay

    Quantity

    10,199 units