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.”

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 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.

 

Date Issued

Company

Warning Letter

 


March 18, 2024

Jiangsu Shenli Medical Production Co., Ltd.


March 18, 2024

Sol-Millennium Medical, Inc.


March 18, 2024

Medline Industries, LP


April 24, 2024

Cardinal Health 200, LLC

 


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.

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

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