FDA Issues Another Import Alert for Chinese Plastic Syringe Manufacturers

On May 16, the FDA announced an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. for not meeting device quality system requirements, to prevent plastic syringes made by these China-based manufacturers from entering the United States.

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.

The FDA recommendations have been updated to include that users should also immediately transition away from using plastic syringes made by these manufacturers, unless use of these syringes is absolutely necessary until the transition to syringes that are not manufactured in China is complete.

The agency 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.

The FDA also updated its recommendations for U.S. suppliers of plastic syringes, consumers, healthcare providers and facilities.

Until further notice and because of potential quality and performance issues, immediately transition away from using plastic syringes manufactured by the following China-based manufacturers, unless use of these syringes is absolutely necessary until you can complete the transition to syringes that are not manufactured in China:

• Jiangsu Caina Medical Co Ltd.
• Jiangsu Shenli Medical Production Co Ltd.
• Shanghai Kindly Enterprise Development Group Co Ltd.
• Zhejiang Longde Pharmaceutical Co Ltd.

For all other plastic syringes made in China, while the FDA’s evaluation remains ongoing, the FDA continues to recommend the following:

• Check the manufacturing location for syringes you use or have in your inventory by reviewing the labeling, outer packaging, or contacting your supplier or group purchasing organization.
• Use syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included.
• If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.
• Report any issues with syringes to the FDA.