The US Food and Drug Administration (FDA) has issued a warning that it is investigating the safety of plastic syringes manufactured in China, which are used for injecting or withdrawing fluids from patients. The notice is a broad warning about potential leaks, breakages, and other issues with all China-made syringes, without citing specific manufacturers. Healthcare providers are advised to consider using syringes not manufactured in China if possible.
The FDA’s action follows information received about quality issues with several unnamed Chinese syringe manufacturers. The warning does not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. Reported quality issues include leaks, breakage, and other problems that occurred after manufacturers altered the syringe dimensions. These issues may impact the performance and safety of the syringes, including their ability to deliver the correct dose of medication when used alone or with medical devices such as infusion pumps.
The FDA is currently working to test China-made syringes and will collaborate with manufacturers to ensure corrective actions are taken or to prevent specific syringes made in China from entering the US market. The agency will continue to monitor safety reports and keep the public informed as more information becomes available.- Flcube.com
