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)