FDA Communications

The U.S. Food and Drug Administration (FDA) is evaluating quality and performance issues related to plastic syringes made in China. As a result of its evaluation, FDA continues to update its November 2023 Safety Communication with additional recommendations and announcements, including announcements regarding Warning Letters, Import Alerts, and recalls related to plastic syringes made in China.

Safety Communication

The FDA Safety Communication also includes important information and recommendations for consumers, health care providers and facilities and U.S. suppliers, including a recommendation to "immediately transition away” from using certain plastic syringes unless “absolutely necessary.” On July 18, 2024, FDA updated its recommendations to include an additional recommendation that users should immediately transition away from using enteral syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. unless use of these syringes is absolutely necessary until the transition to alternative enteral syringes can be completed.

You can read the FDA’s Safety Communication at:

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Warning Letters

The FDA has issued Warning Letters to certain entities that describe violations related to the sale and distribution of distribution of unauthorized plastic syringes made in China as well as violations related to quality system regulations for syringe products. You can read the Warning Letters on FDA’s website at www.fda.gov or by clicking the hyperlinks below.

Import Alerts

The FDA also announced Import Alerts for certain plastic syringe products manufactured by:

• Jiangsu Caina Medical Co. Ltd.
• Jiangsu Shenli Medical Production Co. Ltd.
• Shanghai Kindly Enterprise Development Group Co. Ltd.
• Zhejiang Longde Pharmaceutical Co. Ltd. (Removed by the FDA on August 16, 2024)

These Import Alerts can be found at the following two webpages:

• https://www.accessdata.fda.gov/cms_ia/importalert_241.html
• https://www.accessdata.fda.gov/cms_ia/importalert_244.html