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

FDA’s ongoing investigation into plastic syringes made in China and distributed in the United States has revealed “more widespread” quality issues than originally known, the agency said in an update published today on its website. FDA first reported that it was evaluating the medical syringes on Nov. 30, 2023, after receiving information that the devices did not consistently deliver the correct dose of medication.

FDA said in the update that it has conducted facility inspections for Northfield, IL–based Medline Industries and Chicago-based Sol-Millennium Medical, detained and examined products at the border, and done lab tests of the syringes.

Warning letters issued

On March 18, it issued a warning letter to Jiangsu Shenli Medical Production Co. Ltd., a China-based manufacturer of plastic syringes, and warning letters to Medline and Sol-Millennium Medical, which market and distribute those plastic syringes within the United States. The warning letters describe 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 United States, the agency said in the update.

FDA added that it is also evaluating quality and performance issues related to plastic syringes made by China-based Jiangsu Caina Medical Co. Ltd., which is named in the warning letter sent to Medline. Several plastic syringes from Caina Medical showed “unexpected and unexplained failures,” said FDA.

Leaks, breakage, and other problems

In its initial announcement of the investigation in November, FDA cited reports of leaks, breakage, and other problems that resulted from manufacturers making changes to syringe dimensions. The quality issues, FDA added, may affect the ability to deliver the correct amount of medication when used alone or with other medical devices such as infusion pumps.

While it continues its investigation, FDA recommends transitioning away from plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd. and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. (which includes all models other than the 5-mL luer-lock syringe) unless absolutely necessary. Other plastic syringes made in China may continue to be used as needed until US suppliers, consumers, and healthcare organizations are able to transition to alternatives, and should be closely monitored for leaks, breakage, and other issues, said FDA.

Glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not part of this investigation.