BEUDAMED
    FDA Enforcement Class II Terminated

    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    Recall: Z-2262-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2262-2013
    Event ID
    66049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    August 15, 2013
    Classification Date
    September 20, 2013
    Termination Date
    July 11, 2017
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    Reason

    The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.

    Code Info

    QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974

    Distribution

    Worldwide Distribution, including Nationwide (US) and foreign countries.

    Quantity

    1,182 units