On May 23, the FDA announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected products which includes unauthorized plastic syringes made in China.
In March, we reported that 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.”
In April, we reported 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.
And earlier this month, we reported that 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 May 21, 2024, the FDA announced that Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, initiated a recall to stop using its unauthorized plastic syringes.
The FDA recommendations have not changed. Users should immediately transition away from using plastic syringes made by the following China-based manufacturers, unless use of these syringes is absolutely necessary until the transition to syringes that are not manufactured in China is complete:
- Jiangsu Caina Medical Co Ltd.
- Jiangsu Shenli Medical Production Co Ltd.
- Shanghai Kindly Enterprise Development Group Co Ltd.
- Zhejiang Longde Pharmaceutical Co Ltd.
We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available. A timeline and summary of FDA activities is provided in FDA Actions.
