BEUDAMED
    FDA Enforcement Class II Terminated

    INFINITY DUAL HEMO MCable Pod

    Recall: Z-0942-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0942-2018
    Event ID
    79209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draegar Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 4, 2017
    Classification Date
    March 9, 2018
    Termination Date
    June 15, 2018
    Address
    6 Tech Dr, Andover, MA, 01810-2434, United States

    Description

    INFINITY DUAL HEMO MCable Pod

    Reason

    Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.

    Code Info

    Have the affected revision indexes: 15 or 16 (found on the product label)

    Distribution

    Nationally

    Quantity

    2,760