Silver Spring, Md. — The U.S. Food and Drug Administration is expanding an import alert on all plastic syringes made by Jiangsu Shenli Medical Production Co. Ltd. for not meeting device quality system requirements.
All plastic syringes made by the manufacturer are now banned from entering the United States, according to an April 10 safety communication.
FDA also updated its recommendations to U.S. suppliers of plastic syringes, consumers, health care providers and facilities to "immediately transition away from using all models of plastic syringes, including 5 mL luer lock syringes, manufactured by [Jiangsu Shenli] unless use of these syringes is absolutely necessary until you can complete the transition."
In March, FDA sent warning letters to medical suppliers amid its evaluations of quality and performance issues in plastic syringes made in China.
It announced in November 2023 that it was monitoring reports of safety issues associated with "several Chinese manufacturers of syringes."
It is "taking steps to refuse entry of these devices into the United States" until violations are addressed by the companies, it said in a March 11 letter to Jiangsu Shenli.
FDA found the company, based in Changzhou, marketed plastic piston syringes in the U.S. without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
"We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance," the safety notice said.