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FDA warns Cardinal Health for marketing unapproved Chinese devices

The U.S. health regulator has sent a warning letter to Cardinal Health, opens new tab after an inspection of its facility in Illinois found the company was marketing and distributing unapproved devices made by a Chinese manufacturer.

The U.S. Food and Drug Administration in 2023 recommended against the use of some China-made syringes as it investigated reports of leaks, breakages and other quality problems with such products and last month expanded the guidance.

Cardinal did not immediately respond to a Reuters request for comment.

The drug regulator during its inspection determined that Cardinal was an importer of two types of syringes sold under the Monoject brand.

The FDA, in its letter on Wednesday, said the company was marketing kits which include certain misbranded piston syringes made by China’s Jiangsu Shenli Medical Production and neither had approval for commercial marketing nor as an investigational device.

The syringes are used to inject into or withdraw fluids from the body and to deliver fluid, or medications to a patient’s feeding tube.

The agency had in November warned healthcare providers and facilities not to use Cardinal’s Monoject syringes with patient-controlled pain management pumps and syringe pumps.

The warning to healthcare providers followed the company’s recall over incompatibility concerns with syringe pumps. Reuters

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