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