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.