Saturday, April 20, 2024

FDA Alerts on Chinese-Made Plastic Syringes: A Comprehensive Update and Warning Issuance

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The U.S. Food and Drug Administration (FDA) has recently provided an update regarding the ongoing scrutiny of quality and performance issues associated with plastic syringes produced in China. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), outlined the series of measures being implemented by the agency, including the issuance of warning letters to violative entities.

This initiative underscores the FDA’s heightened efforts to safeguard public health by closely monitoring and addressing the safety of medical devices imported into the United States. The agency’s actions stem from a commitment to ensuring that all medical devices, especially those critical to patient care like syringes, meet the rigorous standards set for safety and efficacy. The investigation into these syringes began after reports surfaced, indicating potential failures that could compromise the delivery of medications, posing a significant risk to patients.

In response, the FDA has expanded its evaluation to include not just a review of the products themselves but also a thorough inspection of manufacturing facilities, border detentions of questionable products, and detailed laboratory testing. This comprehensive approach aims to identify and mitigate any possible risks associated with the use of these syringes, with the ultimate goal of preventing any harm to patients relying on them for their healthcare needs.

FDA Targets Chinese-Made Plastic Syringes for Critical Quality Failures, Issues Warning Letters

On November 30, 2023, the FDA initially communicated safety concerns over certain Chinese-made plastic syringes after identifying potential device failures that could impact the accurate delivery of medication. Since then, the FDA’s rigorous investigation has expanded, encompassing facility inspections, product detentions at borders, and extensive laboratory testing. This heightened scrutiny has led to the discovery that the quality issues with these syringes are more prevalent than previously recognized.

In a decisive move on March 18, 2024, the FDA issued warning letters to Jiangsu Shenli Medical Production Co. Ltd, a manufacturer based in China, and two U.S. firms, Medline Industries, LP, and Sol-Millennium Medical, Inc., which market and distribute these products. These letters highlight unauthorized distribution and quality system regulation breaches concerning the syringes. Furthermore, Jiangsu Caina Medical Co. Ltd is under review for quality issues and failures in performance testing, emphasizing the FDA’s commitment to identifying and rectifying these critical concerns.

Plastic Syringes

FDA Advises Against Using Certain Chinese Syringes, Confirms No Impact on Supply Chain

Given the persistent quality and performance issues, the FDA strongly advises U.S. suppliers, consumers, and healthcare organizations to immediately cease using plastic syringes from Jiangsu Caina Medical Co. Ltd and unauthorized variants from Jiangsu Shenli Medical Production Co. Ltd. This recommendation aims to mitigate risks until safer alternatives can be adopted. For other Chinese-made plastic syringes, the FDA’s stance remains as previously advised, urging cautious use and vigilant monitoring for any defects, while reporting issues promptly.

The FDA reassures that the global supply and manufacturing capacity for plastic syringes, excluding those from China, is sufficiently robust to meet current healthcare demands without causing shortages. This confidence in supply chain resilience supports the recommended transition away from the identified problematic syringes. The FDA is steadfast in its collaboration with various stakeholders to ensure the continued safety of syringe usage in the United States. By maintaining open communication and providing updates, the FDA aims to safeguard public health while addressing the complexities of global medical device supply chains.


Resource: Food and Drug Administration, March 19, 2024

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