The U.S. Food and Drug Administration (FDA) has issued a warning letter to Cardinal Health following an inspection of their Illinois facility. The inspection revealed that Cardinal Health was marketing and distributing unapproved medical devices produced by a Chinese manufacturer.
In 2023, the FDA advised against using certain syringes made in China as it investigated various quality issues such as leaks and breakages, and last month, they expanded this guidance. The inspection identified Cardinal Health as the importer of two types of syringes sold under the Monoject brand.
According to the FDA’s letter, Cardinal Health was found to be marketing kits that included misbranded piston syringes manufactured by Jiangsu Shenli Medical Production in China. These syringes had neither been approved for commercial marketing nor authorized as investigational devices. These syringes are commonly used for injecting or withdrawing fluids from the body and delivering fluids or medications to a patient’s feeding tube.
Additionally, in November, the agency had already warned healthcare providers and facilities against using Cardinal’s Monoject syringes with patient-controlled pain management pumps and syringe pumps due to incompatibility issues, which had led to a company recall.
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