BEUDAMED
    FDA Enforcement Class II Terminated

    HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm

    Recall: Z-0209-2022 · Reported November 17, 2021

    Enforcement

    Recall Number
    Z-0209-2022
    Event ID
    88757
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zhejiang Kindly Medical Devices Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 17, 2021
    Initiation Date
    August 24, 2021
    Classification Date
    November 5, 2021
    Termination Date
    July 21, 2023
    Address
    # 758 Binghai Five Rd., Longwan Dist, Wenzhou, N/A, N/A, China

    Description

    HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm

    Reason

    Potential for difficulty in safety mechanism activation.

    Code Info

    Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.

    Distribution

    U.S. Nationwide distribution.

    Quantity

    N/A