Merit Medical issued an urgent medical device recall notice related to specific products that contain plastic syringes made in China.
Certain lots of Merit products contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Merit received notice from its supplier indicating that it supplied the company with those syringes. All but one size/type of Jiangsu Shenli syringes lack sufficient FDA authorization.
In November 2023, the FDA warned of the potential for device failures with plastic syringes manufactured in China. On March 18, 2024, the FDA issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to three companies, including Jiangsu Shenli. Medline Industries and Sol-Millenium Medical were the other two. Zhejiang Longde and Shanghai Kindly, two more syringe makers, joined the original trio last month.
According to Merit Medical, the FDA cited “growing evidence of potential harm” for Jiangsu Shenli syringes. The agency recommends that, if continued use of the syringes is “absolutely necessary,” until alternatives become available, users should closely monitor for leaks, breakage and other problems. Leaks or breakage may lead to a delay in treatment.
Merit said that, while the recall targets the syringes in its products, the other components remain unaffected. The company requests that customers stop using or distributing the products containing the affected syringes and place them in quarantine.
While companies that make syringes in China continue to grapple with the FDA’s warnings, syringe production is on the rise in the U.S. In response to the FDA’s actions, BD elected to step up domestic production in response to the import bans on those syringes in March.
