BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    Recall: Z-1599-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1599-2021
    Event ID
    87476
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 26, 2021
    Initiation Date
    February 26, 2021
    Classification Date
    May 17, 2021
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    Reason

    Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

    Code Info

    All Lot numbers within active shelf life

    Distribution

    Worldwide distribution.

    Quantity

    213,110 units