UPDATE 1-US FDA sends warning to Cardinal Health for marketing unapproved devices

(Adds details from the agency’s inspection and background from paragraph 2)

April 25 (Reuters) – The U.S. health regulator has sent a warning letter to Cardinal Health after an inspection of its facility in Illinois showed that the company was marketing unapproved devices.

The U.S. Food and Drug Administration (FDA) during its inspection determined that Cardinal was an importer of syringes sold under the Monoject brand.

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

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

The FDA 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)

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