US FDA sends warning letter to Cardinal Health for marketing unapproved devices

[April 26, 2024]  (Reuters) -The U.S. health regulator has sent a warning letter to Cardinal Health 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.

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo/File Photo

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.

(Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj Kalluvila)

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