The FDA has provided a further update on plastic syringes made in China, recommending that “U.S. suppliers, consumers, and healthcare organizations 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. … unless absolutely necessary.”
The FDA had “previously received information about concerns with the performance and safety of these syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.” They now write that “the issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known.”
Because of these issues, the FDA issued a warning letter to Jiangsu Shenli Medical Production Co. Ltd. on March 18 and to two firms marketing and distributing plastic syringes made in China within the U.S. 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 the FDA for use in the U.S.” and “violations related to quality system regulations for syringe products.”
The FDA is also “actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co. Ltd” in the wake of “unexpected and unexplained failures with several Jiangsu Caina plastic syringes.”
The FDA also makes clear that recommendations for all other plastic syringes in China remain unchanged and that the evaluation is ongoing. The agency also believes “the supply and manufacturing capacity of plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current healthcare demand,” so a shortage is not expected.
The FDA’s website has the news release.
