FDA Updates Plastic Syringe Safety Communication

FDA recently announced an update to its safety communication recommending that US suppliers immediately transition away from using plastic syringes manufactured by specific China-based companies. In the update, the agency issued an additional warning letter to Jiangsu Shenli Medical Production — one of the multiple names tacked to the list — for quality system violations for syringe products. As a result, the company’s “entry on import alert 89-04 was expanded to prevent their enteral syringes from entering the United States,” according to the notice.

A warning letter was also issued to Jiangsu Caina Medical for quality system violations.

FDA initially issued a safety communication in late 2023 recommending that consumers transition away from using plastic syringes manufactured in China. At the time, the agency did not name specific companies but said it had received information about quality issues associated with several Chinese manufactures of plastic syringes, including leaks, breakage, and other problems.

By May 2024, the safety communication had been updated to included multiple companies: Zhejiang Longde Pharmaceutical, Shandhai Kindly Enterprise Development Group, Jiangsu Shenli Medical Production, Medline, Sol-Millenium Medical, and Jiangsu Caina Medical.

As part of the evaluation of quality systems, FDA has issued six warning letters:

Six import alerts:

And six recalls:

As part of the most recent update, the agency has extended its recommendations to include transitioning away from the use of enteral syringes manufactured by Jiangsu Shenli Medical Production unless use of these syringes are absolutely necessary until alternatives can be obtained.

“We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available,” FDA wrote in the notice update.

Previous reporting on the plastic syringe safety communication:

FDA Advises Against Use of China-Made Plastic Syringes after Quality Failure Reports

Quality Issues Involving China-made Plastic Syringes ‘More Widespread’ Than FDA Thought

BD Increases US Syringe Production After FDA Warnings on China-Made Syringes

FDA Adds Two New Chinese Manufacturers to Do Not Use Plastic Syringe List