FDA Expands Actions Against Problematic Plastic Syringes from China

FDA Expands Actions Against Problematic Plastic Syringes from China

In a recent update, the U.S. Food and Drug Administration (FDA) has announced expanded measures to address concerns regarding the quality and performance of plastic syringes manufactured in China, with a particular focus on Jiangsu Shenli Medical Production Co. Ltd.

The FDA’s latest actions include the implementation of an import alert, effectively preventing all plastic syringes from Jiangsu Shenli Medical Production Co. Ltd. from entering the United States. This decision stems from the manufacturer’s failure to meet the FDA’s stringent device quality system requirements.

In addition to the import alert, the FDA is strongly recommending that U.S. suppliers, consumers, health care providers, and facilities swiftly transition away from using plastic syringes produced by Jiangsu Shenli Medical Production Co. Ltd., unless their usage is absolutely necessary. Similar recommendations are extended to plastic syringes manufactured by Jiangsu Caina Medical Co Ltd.

The FDA advises stakeholders to carefully check the manufacturing location of plastic syringes and opt for alternatives whenever possible. However, if the only available options are syringes made in China, users are urged to closely monitor for any issues such as leaks or breakage and promptly report such problems to the FDA.

The agency’s ongoing evaluation of plastic syringes from China involves comprehensive measures, including facility inspections, border examinations, laboratory testing, and collaboration with manufacturers. This proactive approach aims to ensure the safety and reliability of medical devices used in the United States.

Furthermore, the FDA emphasizes its commitment to working closely with stakeholders, including other federal agencies, medical device manufacturers, and healthcare organizations, to address these concerns effectively.

As this situation continues to evolve, the FDA pledges to keep the public informed of any new developments or additional information regarding plastic syringes manufactured in China. With these concerted efforts, the FDA aims to safeguard the integrity of medical devices and promote public health and safety.