FDA advises US healthcare organizations to stop using Chinese-made plastic syringes from Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co. due to quality concerns; the recommendation excludes glass and pre-filled syringes

U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.

“The FDA believes that the supply and manufacturing capacity [for] plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current health care demand,” the agency said, adding that it will continue to work with stakeholders to ensure the safety of syringes used in the U.S. “In addition, the FDA will continue our efforts to evaluate problems with syringes made in China and keep the public informed as additional information becomes available.”

The agency this week warned Jiangsu Shenli Medical Production Co., Medline Industries, and Sol-Millennium Medical about violations related to the sale and distribution of unauthorized plastic syringes made in China.