On April 10, the FDA updated its guidance and expanded its actions for Jiangsu Shenli Medical Production Co. Ltd. The FDA issued an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States.
In March, we reported that the FDA recommended that “U.S. suppliers, consumers, and healthcare organizations immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. … unless absolutely necessary.”
The FDA provided an update to its recommendations in the latest guidance:
- 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.
- We remain concerned that certain 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.
