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Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as, leaks, breakage, particles in the syringes, and other problems) with plastic syringes manufactured in China.
The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
The FDA received information about quality issues associated with several Chinese manufacturers of syringes. We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.
At this time, while the FDA continues its evaluation, consider using plastic syringes not manufactured in China, if possible.
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This safety communication provides:
- Recommendations for consumers, health care providers, and health care facilities.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with syringes to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education.
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