Summary:
The U.S. Food and Drug Administration (FDA) has issued a safety communication, notifying consumers, healthcare providers, and facilities about the ongoing evaluation of plastic syringes manufactured in China. The FDA is concerned about potential device failures, such as leaks, breakage, and other issues, affecting the quality and performance of these syringes.
The issue, as of now, does not include glass syringes, pre-filled syringes, or those used for oral or topical purposes. The FDA has received information about quality problems associated with several Chinese syringe manufacturers, prompting this evaluation.
Recommendations for consumers, healthcare providers, and facilities include checking the manufacturing location of syringes, considering alternatives not manufactured in China, and closely monitoring for issues if continuing to use syringes from China. Reporting any problems to the FDA is encouraged.
The FDA is aware of quality issues from recent syringe recalls, Medical Device Reports (MDRs), and complaints related to changes in syringe dimensions made by manufacturers in China. These issues, including leaks and breakage, may impact the safety and performance of syringes, affecting their ability to deliver accurate medication doses.
The FDA is collaborating with federal partners to conduct further testing on syringes from China. Plans are in place to work with manufacturers to implement corrective actions and potentially restrict the entry of syringes from China into the United States if necessary. Ongoing monitoring of reports concerning syringes manufactured in China will continue, and the FDA pledges to keep the public informed as more information becomes available.