Merit Medical is recalling unauthorized plastic syringes, US FDA says

Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) -The U.S. Food and Drug Administration said on Friday that Merit Medical Systems 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 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.

(Reporting by Puyaan Singh in Bengaluru; Editing by Vijay Kishore)