BEUDAMED
    FDA Enforcement Class II Terminated

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    Recall: Z-0810-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0810-2020
    Event ID
    84531
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Suntech Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2020
    Initiation Date
    December 11, 2019
    Classification Date
    January 14, 2020
    Termination Date
    April 10, 2023
    Address
    507 Airport Blvd Ste 117, Morrisville, NC, 27560-8200, United States

    Description

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    Reason

    The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.

    Code Info

    All serial numbers.

    Distribution

    No US Distribution; Internationally distributed to France, S. America

    Quantity

    384 units