BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No

    Recall: Z-2106-2024 · Reported May 29, 2024

    Enforcement

    Recall Number
    Z-2106-2024
    Event ID
    94520
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Jiangsu Shenli Medical Production Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 29, 2024
    Initiation Date
    April 5, 2024
    Classification Date
    June 10, 2024
    Address
    No. 20 Changzheng Road, Zhengluzhen Wujin, Changzhou, N/A, China

    Description

    Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No

    Reason

    Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

    Code Info

    Lot Code: LOT: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006

    Distribution

    U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.

    Quantity

    483210