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US FDA sends warning letter to Cardinal Health for marketing unapproved devices
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US FDA sends warning letter to Cardinal Health for marketing unapproved devices
Apr 25, 2024 12:24 PM

April 25 (Reuters) - The U.S. health regulator has sent

a warning letter to Cardinal Health ( CAH ) 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.

(Reporting by Pratik Jain in Bengaluru; Editing by Shilpi

Majumdar and Sriraj Kalluvila)

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