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 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

    Recall: Z-0160-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0160-2013
    Event ID
    62947
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2012
    Initiation Date
    June 12, 2012
    Classification Date
    October 26, 2012
    Termination Date
    September 29, 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 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

    Reason

    It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.

    Code Info

    All sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U. HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050. HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050. Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX. Note: an X was used to represent variations of catalogue numbers.

    Distribution

    US Nationwide Distribution

    Quantity

    23,203 units