Sol-Millennium Responds to FDA Safety Communication
02 Dec 2023
Preview
Source: Business Wire
Preview
Source: Business Wire
CHICAGO--(BUSINESS WIRE)--Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding the FDA’s November 30 Safety Communication regarding syringes manufactured in China. The notice lists failures such as leaks, breakage, and other potential concerns. The communication does not list manufacturers.
Sol-Millennium's devices undergo rigorous design and development processes ensuring to meet globally recognized ISO standards for their syringe portfolio. Sol-Millennium's manufacturing partners based in China adhere to stringent sampling techniques for raw material, in-process, and final inspections prior to product release.
Sol-Millennium seeks to reassure its customers and their patients that the firm places safety and reliability at the top of its concerns and efforts.
“We have been supplying top-quality medical devices for over a decade in the United States, including over 2 billion syringes and needles for Global Covid-19 Vaccination Campaigns,” said Manu Kalia, Director of Quality Assurance and Regulatory Affairs. “All our manufacturing partners are ISO 13485 certified, ensuring that all material, manufacturing, and testing standards are adhered to for every product we offer. We assure the quality of every product we sell.”
Sol-Millennium Medical Group is one of the world's largest manufacturers of needles and syringes. It is vertically integrated with locations across the globe. Sol-Millennium's innovative technology helps positive patient outcomes, saves on medication, and enhances both clinician and patient experience. With an international sales team dedicated to delivering knowledge and outstanding customer service, Sol-Millennium’s goal is to partner with those in healthcare, focusing on a healthier tomorrow.
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