BEUDAMED
    FDA Enforcement Class II Terminated

    QUADROX-i oxygenators Custom tubing packs for the oxygenator

    Recall: Z-1371-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1371-2016
    Event ID
    73390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    April 12, 2016
    Termination Date
    September 25, 2019
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    QUADROX-i oxygenators Custom tubing packs for the oxygenator

    Reason

    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

    Code Info

    All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx, BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U, X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100

    Distribution

    US Nationwide Distribution.

    Quantity

    72,000 units in total