Jiangsu Shenli Medical Production Co., Ltd.

The United States Food and Drug Administration (FDA) has learned that your firm is marketing Jiangsu Shenli Medical Production Co. Ltd. piston syringes of the sizes and configurations listed in Table 1 below in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Model # Item Description Model # Item Description

83077 SYR 30ML L/S 91839 SYR 20ML L/L YELLOW

83078 SYR 30ML L/L 91840 SYR 3ML L/L PURPLE

83079 SYR 60ML L/S 91841 SYR 5ML L/L PURPLE

83080 SYR 60ML L/L 91842 SYR 10ML L/L PURPLE

83081 SYR 10ML L/S 91845 SYR 20ML L/L BLUE SALINE

83082 SYR 10ML L/L 91846 SYR 10ML L/L YELLOW CONT

83083 SYR 3ML L/S 91847 SYR 10ML L/L BLUE LIDO

83084 SYR 3ML L/L 91849 SYR 10ML L/L BLUE SALINE

83085 SYR 5ML L/S 91850 SYR 10ML L/L RED LIDO

83087 SYR 20ML L/S 91851 SYR 10ML L/L RED HEPARIN

83088 SYR 20ML L/L 91852 SYR 5ML L/L YELLOW NITRO

83089 SYR 1ML TB 91854 SYR 10ML L/L YELLOW LIDO

91820 SYR 3ML L/L RED 91855 SYR 10ML L/L YELLOW HEP/SALINE

91821 SYR 3ML L/L GREEN 91856 SYR 10ML L/L RED CONT

91822 SYR 3ML L/L BLUE 91857 SYR 10ML L/L GREEN CONT

91825 SYR 5ML L/L RED 91858 SYR 20ML L/L WHITE SALINE

91826 SYR 5ML L/L GREEN 91859 SYR 5ML L/L PURPLE NITRO

91827 SYR 5ML L/L BLUE 91863 SYR 20ML L/L YELLOW LIDO

91828 SYR 5ML L/L WHITE 91866 SYR 5ML L/L RED NITRO

91829 SYR 5ML L/L YELLOW 91867 SYR 5ML L/L BLUE HEPARIN

91830 SYR 10ML L/L RED 91872 SYR 10ML L/S BLUE

91831 SYR 10ML L/L GREEN 91873 SYR 10ML L/L WHITE LIDO

91832 SYR 10ML L/L BLUE 91874 SYR 10ML L/S RED

91833 SYR 10ML L/L WHITE 91876 SYR CNTRL 10ML L/L YEL 1

91834 SYR 10ML L/L YELLOW 91877 SYR CNTRL 10ML L/IL YELLOW LIDO

91835 SYR 20ML L/L RED 91878 SYR CNTRL 10 ML L/L RED

91836 SYR 20ML L/L GREEN 91879 SYR CNTRL 10ML L/L GRN

91837 SYR 20ML L/L BLUE 91880 SYR CNTRL 10ML L/L BLUE

91838 SYR 20ML L/L WHITE 91881 SYR 10ML L/L CONTROL

Table 1. List of Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations implicated in this Warning Letter.

Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has determined, based on information provided by your firm and information available on the Agency's public databases, that the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in Table 1 are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(0(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with (1) major changes or modifications to the intended use, and/or (2) a change or modification in the device that could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i)-(ii).

Specifically, the Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock) was cleared under K103830 with the following indications for use: The intended use of the Jiangsu Shenli Medical Production Co., Ltd. 5cc luer lock piston syringe is to inject fluids into or withdraw fluids from the body. Based on FDA's evaluation of your firm's activities, there is evidence that your firm is engaged in the distribution of syringes for use within the United States with substantially different technological characteristics, namely sizes other than 5 mL, luer slip instead of luer lock tips, syringes intended for specific drugs, different colors (i.e., colorants), and control syringes, each of which constitute a significant change or modification in design that could significantly alter the safety or effectiveness of the device. For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, it is recommended you consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." In the guidance at Figure 3 — Flowchart B: Technology, Engineering, and Performance Changes, FDA explains why changes in size, color, specific drug indications and connector type all constitute a major change or modification to the device's intended use, for which your firm lacks clearance or approval.

As discussed above the products listed in Table 1 are misbranded because you made one or more change(s) or modification(s) to each device that could significantly affect the safety or effectiveness of the device without submitting a 510(k) to FDA. Specifically, changing the volume of the syringe, switching from a luer lock to a luer slip syringe tip, and changing from a traditional syringe to a control syringe could result in the risk of patient harm such as inaccurate dosing, a leaking device, a higher risk of inappropriate needle detachment, and incorrect device handling. Furthermore, the addition of color additives to your syringe could result in adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure. Labeling the syringe for a specific drug can also cause harm because differences in drug viscosities impact the function of the syringe and can result in patient harm such as inaccurate dosing or incorrect drug usage.

Your firm's failure to submit 510(k)s for these devices has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes. Further, FDA has observed evidence of postmarket safety signals indicating product quality issues that have the potential to cause serious patient harm. Specifically, FDA is aware of multiple customer complaints regarding quality issues (e.g. cracks, breakage during use) for syringes in surgical kits supplied by Jiangsu Shenli Medical Production Co. Ltd.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

FDA requests that Jiangsu Shenli Medical Production Factory cease any activities that result in the misbranding or adulteration of all the Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations listed in Table 1, such as the commercial distribution of the device sizes, configurations, and uses discussed above, including selling to initial importers, distributors, or other third parties for distribution and use within the United States or otherwise representing these devices to have the requisite clearance or authorization for marketing in the United States.

Given the serious nature of the violations of the Act and growing evidence of potential harm, all the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in Table 1 are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, until these violations are addressed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm's response should be sent by email to CDRHWamingLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration Center for Devices and Radiological Health Office of Regulatory Programs Division of Regulatory Programs 2: Establishment Support Regulatory Inspections and Audits Team White Oak Building 66 10903 New Hampshire Ave. Silver Spring, MD 20993

Refer to the identification number CMS # 677753 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Shruti Misty at Shruti.Mistry@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.