FDA Warns Medical Industry to “Transition Away” from Certain Chinese-Made Syringes
Warning letters over plastic syringe problems were sent to both Chinese manufacturers and U.S. distributors, due to quality control and safety issues.
Federal regulators are raising the alarm over problems with plastic syringes made in China, which may break or deliver incorrect doses, resulting in medication errors that could be life-threatening.
The U.S. Food and Drug Administration (FDA) issued a plastic syringe safety update on March 19, calling for healthcare providers and the medical industry as a whole to stop using certain syringes as soon as possible, and transition to another manufacturer.
The safety review began after November 30, 2023, when the FDA warned of potential problems with plastic syringes manufactured in China, indicating that the agency had received reports of syringes breaking, leaking, and suffering other quality issues.
The initial warning notice indicated the syringes may not function properly and may not deliver the correct dose of medication when used alone or with other medical devices like an infusion pump. However, at the time, the agency did not name a specific manufacturer.
FDA Chinese Syringe Investigation
As part of the investigation, FDA investigators performed facility inspections and examined syringes at distributor facilities at Medline Industries, LP and Sol-Millennium Medical Inc. The agency also conducted laboratory testing and detained products that did not adhere to U.S. standards.
The evaluation determined the issues with the quality of the plastic syringes are far more widespread than originally believed. FDA inspectors found that the issues stem from manufacturers based in China and involves distributors in the United States.
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Learn MoreThe FDA conducted facility inspections and syringe testing at Jiangsu Shenli Medical Production Co Ltd products, based in China, and at distributors Medline Industries LP and Sol-Millennium Medical Inc., both based in Illinois.
As a result, on March 18 the agency issued warning letters to all three companies outlining serious manufacturing violations, safety and quality control issues related to the plastic syringes, which are not cleared or approved by the FDA. The letters call for the companies to take corrective actions to address the issues.
The FDA indicates it is continuing to conduct investigations to ensure there are no other products, manufacturers, or distributors involved with the issue.
FDA Syringe Recommendations
The FDA recommends healthcare providers, consumers, and suppliers in the U.S. stop using plastic syringes manufactured by Jiangsu Shenli and Jiangsu China or distributed by Medline or Sol-Millennium and transition to products from another manufacturer as soon as possible.
The agency indicates health care providers can use the syringes as needed until they can switch to an alternative product, and closely monitor the syringes for leaks, breaks, and other issues.
Glass syringes, pre-filled syringes, and syringes used for oral and topical uses are not part of the investigation and may continue to be used.
Any problems related to the use of plastic syringes manufactured in China should be reported to the FDA’s MedWatch Adverse Event Reporting program.
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