By :- Team VOH
16 Jun 2024
The U.S. Food and Drug Administration (FDA) announced on Friday that Merit Medical Systems has initiated a recall for unapproved plastic syringes supplied by Jiangsu Shenli Medical Production, a China-based company.
In 2023, the FDA advised against using certain syringes from China after receiving reports of leaks, breakages, and other quality issues. Merit Medical responded by transitioning away from Jiangsu Shenli syringes and requested a halt in using or distributing products containing the affected syringes.
Earlier this year, in March, the FDA issued warning letters to Medline Industries, Sol-Millennium Medical, and Jiangsu Shenli for violations related to the sale and distribution of unauthorized plastic syringes. Jiangsu Shenli had already initiated a recall for its unauthorized syringes in May.
Additionally, Cardinal Health received a warning letter in April following an inspection of its Illinois facility, which revealed the marketing and distribution of unapproved Jiangsu Shenli syringes.
The FDA stated that it will continue to evaluate and address issues with syringes manufactured in China.
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