On May 8, 2024, Sol-Millennium Medical, Inc. initiated a recall to stop using affected products, which includes unauthorized plastic syringes made in China such as “combined” syringes with needle and syringe components packaged together, low dead space (“LDS”) syringes, luer slip tip syringes, eccentric tip syringes, and syringe accessories.
The FDA recommendations have not changed.
The FDA says it will continue its efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
On April 10, the FDA updated its guidance and expanded its actions for Jiangsu Shenli Medical Production Co. Ltd. The FDA issued an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States.
In March, we reported that the FDA recommended 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.”
