 
Today, the U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China. Specifically, the FDA is announcing the issuance of an additional warning letter to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products. As a result, Jiangsu Shenli Medical Production Co., Ltd.’s entry on import alert 89-04 was expanded to prevent their enteral syringes from entering the United States.
A warning letter was also issued to Jiangsu Caina Medical Co Ltd. for quality system violations.
The FDA recommendations have been updated to include that users should also 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 enteral syringes manufactured by a different manufacturer can be completed.
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. We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
Questions?
If you have questions about this communication, contact the Division of Industry and Consumer Education.
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