WASHINGTON, D.C. — The Food and Drug Administration (FDA) has issued additional warnings regarding plastic syringes made by Jiangsu Shenli Medical Production Co., Ltd. The agency’s ongoing evaluation has uncovered significant quality and performance issues with these products.
The FDA expanded the company’s entry on import alert 89-04, now blocking their enteral syringes from entering the United States. This move comes after the FDA found quality system violations in the production of these syringes. The agency has also recommended that users immediately transition away from using these syringes unless absolutely necessary.
In addition to Jiangsu Shenli, the FDA has issued a warning letter to Jiangsu Caina Medical Co. Ltd. for similar quality system violations. These actions are part of the FDA’s broader effort to ensure the safety and effectiveness of medical devices used in the U.S.
The FDA’s recommendations are crucial for healthcare providers who rely on enteral syringes for patient care. The agency advises transitioning to syringes from other manufacturers to avoid any potential risks associated with the compromised products from Jiangsu Shenli.
For now, the FDA urges all users of enteral syringes from Jiangsu Shenli to find alternative products as soon as possible to ensure patient safety.
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