On June 14, the FDA announced a recall initiated by Merit Medical Systems, Inc. in direct response to the Jiangsu Shenli Medical Production Co Ltd. recall to stop using its unauthorized plastic syringes. Merit includes the affected Jiangsu Shenli syringes in multiple kits.
The FDA recommendations have not changed.
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.
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.”
