BEUDAMED
    FDA Recall 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 · Initiated August 24, 2021

    Recall

    Recall Number
    Z-0209-2022
    Event Number
    88757
    Firm
    Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China
    FEI Number
    3003560965
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 24, 2021
    Terminated
    July 21, 2023

    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.

    Action

    On 8/24/2021, Zhejiang Kindly Medical Devices Co., Ltd. issued Urgent Medical Device Safety Alert notices to two customers. On 9/17/2021, issued a second notice to customers dated 8/24/2021. Action to be Taken by User: 1 - Advise the user to lower the angle between safety protective cap and needle tube by slight pressing in the direction of activation, then using a thumb or hard surface to activate the safety protective cap and lock the needle tube in the IFU, then together with corresponding illustration. 2 - Request the user to strictly follow the guidance of the IFU.

    Distribution

    U.S. Nationwide distribution.