The U.S. Food and Drug Administration has cracked down on imports of plastic syringes from China as the agency has raised concerns about quality issues.
In November, the FDA said it was evaluating the potential for syringes to suffer problems such as leaks and breakages and advised healthcare providers to “consider using syringes not manufactured in China, if possible.”
Since then, the FDA has taken further actions, including issuing import bans to manufacturers Jiangsu Shenli Medical Production, Jiangsu Caina Medical, Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group. The actions came ahead of the Biden administration raising tariffs on medical products imported from China.
The FDA sent a warning letter to Jiangsu Shenli in March after learning it sold piston syringes in different sizes and configurations than were cleared for use. The agency has also sent warning letters to Cardinal Health, Medline Industries and Sol-Millennium Medical for selling the imported syringes, which the FDA says have not been authorized for distribution in the U.S.
Cardinal, Medline and Merit Medical Systems are among the companies that have since recalled affected syringes.
Here are the latest actions related to the FDA’s scrutiny of imported syringes: