BEUDAMED
    FDA Recall Terminated

    INFINITY DUAL HEMO MCable Pod

    Recall: Z-0942-2018 · Initiated October 4, 2017

    Recall

    Recall Number
    Z-0942-2018
    Event Number
    79209
    Firm
    Draegar Medical Systems, Inc.
    FEI Number
    3005783425
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 4, 2017
    Terminated
    June 15, 2018
    Address
    6 Tech Dr, Andover, MA, 01810-2434

    Description

    INFINITY DUAL HEMO MCable Pod

    Reason

    Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger 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.

    Action

    In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)

    Distribution

    Nationally

    Quantity

    2,760