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Jiangsu Shenli Medical Production Co., Ltd. was cited for marketing multiple piston syringe models in the United States without obtaining the required FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The warning covered approximately 50 syringe configurations across various sizes (1mL to 60mL) and formulations, including models with different needle gauges and pre-filled solutions such as saline, lidocaine, heparin, and nitroglycerin. The company's unlicensed distribution of these medical devices represented a significant compliance failure in the regulatory authorization requirements for Class II and Class III medical devices.