BEUDAMED
    FDA Recall Terminated

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    Recall: Z-0251-2020 · Initiated September 18, 2019

    Recall

    Recall Number
    Z-0251-2020
    Event Number
    83896
    Firm
    Senseonics, Inc.
    FEI Number
    3009862700
    Product Code
    QHJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 18, 2019
    Terminated
    July 30, 2020
    Address
    20451 Seneca Meadows Pkwy, Germantown, MD, 20876-7005

    Description

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    Reason

    Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

    Action

    Senseonics issued Urgent Medical Device recall letter to HCPs and Distributors as two separate pdf documents) issued on Sep 18 as UPS next day (by noon) delivery. Letter states reason for recall, health risk and action to take: If you have inserted one of these sensors, there is no reason to remove it from the patient and replace it unless it prematurely stops functioning. Replacement Alert on the Eversense app. However, if any of these sensors are in inventory awaiting insertion at your office, DO NOT INSERT THESE SENSORS. Please immediately check your inventory for the identified serial numbers and quarantine affected stock on hand. We will replace affected sensors in your inventory. Please immediately complete the attached stamped and addressed response card and check your product status. Contact your Eversense sales representative or Customer Care at 1-844 SENSE4U (844-736-7348) 24 hours/7 days-a-week if you have any questions.

    Distribution

    Nationwide

    Quantity

    1,344 Sensors