FDA Alert: Chinese Syringe Maker Jiangsu Shenli Initiates Voluntary Recall

This week, the US Food and Drug Administration (FDA) provided a status report on its ongoing assessment of quality and performance issues concerning plastic syringes manufactured in China. The update highlighted that Jiangsu Shenli Medical Production Co., Ltd, a Chinese company, has voluntarily initiated a recall to halt the distribution and use of its unauthorized plastic syringes. This action follows the FDA’s initial announcement in November 2023 to investigate the quality of such imported medical devices.

The FDA continues to advise users to cease using plastic syringes from specific Chinese manufacturers unless it is absolutely essential until an alternative, non-Chinese source is secured. The affected manufacturers include Jiangsu Caina Medical Co., Ltd, Jiangsu Shenli Medical Production Co., Ltd, Shanghai Kindly Enterprise Development Group Co., Ltd, and Zhejiang Longde Pharmaceutical Co., Ltd. The agency’s directive underscores the importance of patient safety and the integrity of medical supplies.- Flcube.com

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