FDA advises against using plastic syringes made in China
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 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.
鈥淭he 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,鈥 the agency said, adding that it will continue to work with stakeholders to ensure the safety of syringes used in the U.S. 鈥淚n 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.鈥
The agency this week 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.