FDA Warns of Potential Issues with China-made Syringes

In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to assess the quality and performance of plastic syringes used for injecting or withdrawing fluids from the body. 

The FDA has received information indicating quality issues with syringes from several Chinese manufacturers, raising concerns about their consistency and adequacy in terms of quality and performance. Notably, this evaluation does not encompass glass syringes, pre-filled syringes, or those intended for oral or topical use. 

Recommendations for Consumers, Health Care Providers, and Facilities

• Verify the manufacturing location of syringes by checking labeling, outer packaging, or contacting suppliers. 
• Consider alternatives to syringes manufactured in China, if feasible. 
• If only Chinese-manufactured syringes are available, continue using them while monitoring closely for issues such as leaks and breakage. 
• Report any problems with syringes to the FDA. 

Device Description and Potential Failures

Syringes are commonly used to administer or withdraw fluids from the body, both in clinical and home health settings. Quality issues reported include leaks and breakage, potentially affecting the accuracy of medication dosages, particularly when used with other medical devices such as infusion pumps. 

FDA Actions

The FDA is collaborating with federal partners to conduct further testing on syringes made in China. Manufacturers will be engaged to implement corrective actions, and regulatory measures may be employed to prevent the entry of problematic syringes into the U.S. Additionally, ongoing monitoring of reports related to Chinese-manufactured syringes will continue. 

Reporting Problems to the FDA

Consumers and healthcare professionals are encouraged to report any issues with syringes or other medical devices through the FDA’s MedWatch Voluntary Reporting Form. Healthcare facilities subject to FDA reporting requirements should follow established reporting procedures. Stay informed and vigilant about syringe safety, and promptly report any concerns to ensure patient well-being. 

Links

For inquiries, individuals can reach out to the Division of Industry and Consumer Education (DICE) via email at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100. 

FDA has archived its original warning notice, click here to read that notice. 

Read the FDA’s update on its investigation into faulty plastic syringes made in China here.