Update on Plastic Syringe Safety

Today, the U.S. Food and Drug Administration (FDA) provided a crucial update regarding the quality and performance issues associated with plastic syringes made in China. This announcement follows the agency’s previous safety communication issued on November 30, 2023, which highlighted concerns about potential device failures with certain plastic syringes made in China. 

FDA issues warning letters

The FDA’s ongoing evaluation has revealed that issues with the quality and distribution of plastic syringes made in China are more widespread than initially known.

In response, on March 18, 2024, the FDA issued warning letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer, and to Medline Industries, LP and Sol-Millennium Medical, Inc., two firms marketing and distributing these syringes in the U.S.

The warning letters address violations related to the sale and distribution of unauthorized plastic syringes made in China, as well as quality system regulations for syringe products. 

Further assessment

Furthermore, the FDA is actively assessing quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co. Ltd, another China-based manufacturer. Unexpected and unexplained failures have been observed during performance testing of several Jiangsu Caina plastic syringes. The FDA’s evaluation of this matter is ongoing, and additional steps will be taken as deemed necessary. 

Additional FDA recommendations

In light of these findings, the FDA is providing additional recommendations to its November 2023 safety communication. The agency now advises U.S. suppliers, consumers, and healthcare organizations to immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd (excluding the 5 mL luer lock syringe), unless absolutely necessary, until the transition is complete. For all other plastic syringes made in China, the recommendations remain unchanged from the November 2023 communication. 

Importance of close monitoring

The FDA emphasizes the importance of closely monitoring for issues such as leaks and breakage with plastic syringes and reporting any problems to the FDA. It’s essential to note that this issue does not pertain to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. 

Supply chain issues not anticipated

Importantly, the FDA assures that the supply and manufacturing capacity of plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current healthcare demand. Therefore, the agency does not anticipate a shortage of these products due to any potential shift in the supply chain. 

FDA commitment

The FDA remains committed to working with stakeholders to ensure the safety of syringes used in the U.S. The agency will continue to evaluate problems with syringes made in China and provide updates to the public as new information becomes available. Stay informed and prioritize patient safety. 

Links 

Read the full FDA announcement here.  

Read a summary of the November 2023 warning here.