BEUDAMED
    FDA Enforcement Class II Ongoing

    Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25

    Recall: Z-1507-2022 · Reported August 17, 2022

    Enforcement

    Recall Number
    Z-1507-2022
    Event ID
    90224
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Guangdong Haiou Medical Apparatus Co., Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 17, 2022
    Initiation Date
    June 10, 2022
    Classification Date
    August 5, 2022
    Address
    Nanyuan Industrial, Zone, North Liusha, Puning, N/A, China

    Description

    Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25

    Reason

    Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user

    Code Info

    Lot Number: 20JC2 Exp. Date: 2025/10/17; 21AA0 Exp Date: 2026/01/04

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    7,218,000 units