BEUDAMED
    FDA Enforcement Class II Terminated

    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

    Recall: Z-0025-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0025-2020
    Event ID
    82763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AURIS HEALTH INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    April 19, 2019
    Classification Date
    November 15, 2019
    Termination Date
    January 19, 2022
    Address
    150 Shoreline Dr, N/A, Redwood City, CA, 94065-1400, United States

    Description

    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

    Reason

    Reports of aspirating biopsy needle breakage

    Code Info

    Lots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1

    Distribution

    US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

    Quantity

    158