In a recent announcement, the U.S. Food and Drug Administration (FDA) has expressed growing concerns regarding the quality and performance of plastic syringes manufactured in China. The agency has taken decisive action to protect public health by issuing an import alert for two major China-based manufacturers, Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd., effectively barring their products from entering the United States.
The FDA’s decision comes after a thorough evaluation of potential device failures, such as leaks, breakage, and other problems associated with plastic syringes produced by several Chinese manufacturers. These quality issues pose significant risks to patient safety and may compromise the accurate delivery of medication, particularly when used in conjunction with medical devices like infusion pumps.
In light of these findings, the FDA strongly recommends that healthcare providers, facilities, and consumers immediately transition away from using plastic syringes manufactured by Zhejiang Longde Pharmaceutical Co. Ltd., Shanghai Kindly Enterprise Development Group Co. Ltd., Jiangsu Caina Medical Co Ltd., and Jiangsu Shenli Medical Production Co Ltd. The agency advises using alternative syringes not manufactured in China whenever possible. However, if Chinese-manufactured syringes are the only option available, the FDA urges close monitoring for any signs of malfunction and prompt reporting of any issues to the agency.
The FDA’s actions extend beyond the import alert, as evidenced by the warning letters issued to three entities in March 2024 regarding the sale and distribution of unauthorized Chinese-made plastic syringes that have not received FDA clearance or approval. The agency is actively working with manufacturers to ensure that adequate corrective measures are implemented to address the identified violations and quality concerns.
As part of its ongoing efforts to safeguard public health, the FDA is conducting extensive evaluations of the problems associated with Chinese-manufactured plastic syringes. These efforts include facility inspections, border examinations, product detention when necessary, and laboratory testing. The agency is committed to monitoring all available data sources for reports of issues related to these syringes and will keep the public informed as new information emerges.
While the situation continues to evolve, the FDA remains confident that the current supply and manufacturing capacity of plastic syringes produced in countries other than China, including domestic production, is sufficient to meet the healthcare demands of the United States.
The FDA’s proactive stance on this matter highlights the agency’s dedication to ensuring the safety and efficacy of medical devices used in the U.S. healthcare system. By taking timely and appropriate action, the FDA aims to mitigate potential risks associated with Chinese-manufactured plastic syringes and protect patients from harm. As always, the agency encourages healthcare professionals and consumers to stay informed and report any adverse events or quality issues related to medical devices promptly.
In light of the recent FDA announcement regarding the potential dangers posed by plastic syringes manufactured in China, TruLaw is here to help you fight for the justice and compensation you deserve. If you or someone you care about has experienced adverse effects, injuries, or complications due to the use of defective Chinese-made plastic syringes, you may be entitled to significant financial recovery. To learn about how we can help you fight for fair compensation, contact us online or try out our free Instant Case Evaluation ℠.