BEUDAMED
    FDA Enforcement Class II Terminated

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    Recall: Z-0771-2023 · Reported January 4, 2023

    Enforcement

    Recall Number
    Z-0771-2023
    Event ID
    91275
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remington Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 4, 2023
    Initiation Date
    December 2, 2022
    Classification Date
    December 28, 2022
    Termination Date
    March 16, 2026
    Address
    6830 Meadowridge Ct, Alpharetta, GA, 30005-2202, United States

    Description

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    Reason

    The stylet is longer than specified on the label

    Code Info

    UDI/DI 00813079020936, Lot Number 2224920, exp. 2025-09/06

    Distribution

    NC, WV, CA, PA, AL, TX

    Quantity

    290 devices