April 24, 2024- The FDA announced expanded actions for Jiangsu Shenli Medical Production Co. Ltd. on April 10, 2024, with an additional import alert for not meeting device quality system requirements, and to prevent ALL plastic syringes by this manufacturer from entering the United States. This comes after an FDA update on March 19, when the FDA evaluated potential device failures with plastic syringes manufactured in China.
Until further notice and because of potential quality and performance issues, the agency recommends that U.S. suppliers of plastic syringes, consumers, health care providers and facilities immediately transition away from using all models of plastic syringes (including 5 mL luer lock syringes) manufactured by Jiangsu Shenli Medical Production Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.
The FDA is concerned that syringes manufactured in China may not provide consistent and adequate quality or performance, and continue to have recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities.