FDA updates warning about plastic syringes made in China

Editor's Note

An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality and performance issues:

• “Immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.”
• “Immediately transition away from using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd, which includes all models other than the 5 mL luer lock syringe, unless use of these syringes is absolutely necessary until you can complete the transition.”

FDA continues to recommend using syringes manufactured outside of China, and to closely monitor for leaks, breakage and other problems if this is not possible. For syringes manufactured in China, check the manufacturing location (found on the package or by contacting the supplier) to ensure it is not from one of the offending manufacturers.

At this time, the agency’s recommendations do not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

On March 18, 2024, the agency issued warning about unauthorized plastic syringes made in China to the following three entities:

• Jiangsu Shenli Medical Production Co. Ltd. (China-based manufacturer of plastic syringes)
• Medline Industries, LP (firm marketing and distributing plastic syringes made in China within the U.S.)
• Sol-Millennium Medical, Inc. (firm marketing and distributing plastic syringes made in China within the U.S.)

“The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also concern violations related to quality system regulations for syringe products,” the agency reports. “The FDA expects these entities to fully address the violations described in the warning letters. In addition, we are actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP. The FDA will take additional steps as appropriate.”