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

FDA has updated its recommendation for healthcare providers concerning not using plastic syringes made in China to include an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shandhai Kindly Enterprise Development Group Co. Ltd. The alert, which will prevent plastic syringes made by these China-based manufacturers from entering the United States, pertains to the companies no meeting device quality system requirements.

FDA initially issued a safety communication informing consumers of potential device failure with plastic syringes manufactured in China late last year. At the time, the agency did not name any specific companies, but, according to previous MD+DI reporting, said it had “received information about quality issues associated with several Chinese manufacturers of plastic syringes including leaks, breakage, and other problems and recommended that consumers, healthcare providers, and facilities not use syringes manufactured in the country if possible.”

After the notice, the industry began speculating about the potential companies involved in the communication, like Cardinal Health and Fresenius Medical Care. The connection was notable since the late 2023 notice came only two weeks after the agency issued a Class I recall to both Cardinal and Fresenius in relation to disposable syringes, listing similar quality issues highlighted in the safety communication, such as leaks and changes to syringe dimensions. However, at this time neither company has been named alongside the others specifically mentioned in the safety communication.

Months after the communication, FDA then published an update to the syringe quality issue investigation, writing it had conducted facility inspections for Medline Industries, and Sol-Millenium Medical, detained and examined products at the border, and done lab tests on the syringes.

On March 18, the agency issued warning letters to three companies: Jiangsu Shenli Medical Production — a China-based manufacturer of plastic syringes, Medline, and Sol-Millenium Medical — which market and distribute those plastic syringes within the US.

The warning letters described violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by FDA for use in the US. Additionally, in its warning letter to Medline, FDA said it is also evaluating quality and performance issues related to plastic syringes made by China-based Jiagngsu Caina Medical, citing “unexpected and unexplained failures” seen in several plastic syringes.

In the May update, the agency added Zhejiang Longde Pharmaceutical and Shandhai Kindly Enterprise Development Group to its list of manufacturers it is recommending healthcare providers not use for plastic syringes. The list also includes Jiangsu Caina Medical and Jiangsu Shenli Medical Production.

Outside of the four specific manufacturers mentioned, FDA is recommending facilities use syringes not manufactured in China, if possible. If a facility only has syringes manufactured in China available, the agency said to “continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.”