The U.S. Food and Drug Administration has issued import warnings against more plastic syringes manufactured in China.
On May 16, FDA issued an updated safety alert urging health care providers to stop using plastic syringes made by Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd.
The alert is the latest in a series of warnings about syringes that FDA says do not meet device quality requirements.
The issue first became public in November, when FDA announced that it was evaluating the potential for device failures such as leaks, breakage, and other problems with plastic syringes manufactured in China.
The syringes in question are used for injecting fluids into, or withdrawing fluids from, the body. The issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
On March 18, FDA issued warning letters to three companies — one Chinese manufacturer and two U.S.-based distributors:
• Jiangsu Shenli Medical Production Co. Ltd., a China-based manufacturer of plastic syringes.
• Medline Industries LP, a Northfield, Ill.-based medical products distributor.
• Sol-Millennium Medical Inc., a Chicago-based medical products distributor.
On April 24, FDA also warned Dublin, Ohio-based Cardinal Health Inc. to stop sales of imported plastic syringes made by Jiangsu Shenli.
In the May 16 alert, FDA named four China-based manufacturers, warning health care providers not to use syringes from these companies "unless use of these syringes is absolutely necessary," and to transition to syringes that are not manufactured in China.
In addition to Jiangsu Shenli, Zhejiang Longde and Shanghai Kindly, the other company named by FDA is Jiangsu Caina Medical Co. Ltd.
Meantime, President Joe Biden announced on May 14 that the U.S. will increase the tariff rate on Chinese syringes and needles from zero to 50 percent. Syringes were part of a list of Chinese-made products that also covers some other plastic medical products.
Medical molders including Becton Dickinson & Co. and Germany's Schott Pharma AG & Co. have announced plans to expand syringe production in the U.S.