FDA Checking Chinese Syringe Safety

FDA says it is evaluating the potential for device failures such as leaks, breakage, and other problems involving plastic syringes made in China. An agency safety communication says FDA is collecting and analyzing data to evaluate plastic syringes made in China 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 notice says.

FDA says it has received information about quality issues associated with several Chinese syringe manufacturers. “We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” it cautions.

The safety communication has recommendations for consumers, healthcare providers, and facilities; a device description; potential syringe failures, and FDA actions.