The FDA is intensifying actions regarding plastic syringes from China due to quality issues. Import alerts have been issued for Jiangsu Shenli Medical Production Co. Ltd., preventing their syringes from entering the U.S. Additional recommendations advise transitioning away from these syringes unless absolutely necessary. Warning letters have been sent to entities involved in distributing unauthorized syringes. The FDA urges vigilance, recommending monitoring for potential failures and reporting any issues. The agency assures an adequate supply of syringes from other sources and pledges ongoing evaluation and communication on the matter.1
You can read the full safety announcement here.
References
- Center for Devices and Radiological Health. (2024, April 10). UPDATE: Evaluating plastic syringes made in China for potential device failures: FDA Safety Communication. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication
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