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Merit Medical is recalling unauthorized plastic syringes, US FDA says
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Merit Medical is recalling unauthorized plastic syringes, US FDA says
Jun 14, 2024 3:14 PM

June 14 (Reuters) - The U.S. Food and Drug

Administration said on Friday that Merit Medical Systems ( MMSI )

has initiated a recall for unapproved plastic syringes

supplied by China-based Jiangsu Shenli Medical Production.

The FDA in 2023 recommended against the use of some syringes

originating from China as it investigated reports of leaks,

breakages and other quality problems with such products.

Merit said it is taking actions to immediately transition

away from Jiangsu Shenli syringes, and has also requested to

stop the use or distribution of products containing affected

syringes.

In March, the FDA also issued warning letters to Medline

Industries and Sol-Millennium Medical along with Jiangsu Shenli

describing violations related to the sale and distribution of

unauthorized plastic syringes made in China.

Jiangsu Shenli had initiated a recall in May for its

unauthorized plastic syringes, said the regulator.

Cardinal Health ( CAH ) was also sent a warning letter in

April after an inspection of its facility in Illinois found the

company was marketing and distributing unapproved syringes made

by Jiangsu Shenli.

The regulator said it will continue efforts to evaluate

problems with syringes made in China.

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