Chicago, IL, March 21, 2024 – Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding March 19th update to the FDA’s Safety Communication (“Evaluating Plastic Syringes Made in China for Potential Device Failures”) and a Warning Letter to Sol-Millennium.
After multiple communications with the FDA, we are confident that all the issues can be resolved. Since November 2023, Sol-Millennium has been providing reports of actions it has taken to address any findings identified in the Warning Letter. These are regulatory in nature.
The principal focus of the Warning Letter is on our 510(k) and whether our “combination” products (needle + syringe attached) constitute a significant change or modification in design that could significantly alter the safety and effectiveness of the devices. The 510(k) for our needle and the 510(k) for our syringe as separate items are not in question by the FDA. We are in the process of submitting applications for premarket clearance for the combination product to address this observation. For the needle and the syringe combination products, we offer them separately (unattached) under our own cleared Sol-Millenniums’ 510(k)s.
Since September 2023, the FDA has inspected approximately one third of Sol-Millennium’s inbound shipments into the United States, including multiple lab tests, and has had zero quality concerns.
Sol-Millennium has no relationship with Jiangsu Caina Medical Co Ltd, and Jiangsu Shenli Medical Production Co Ltd. These are the two manufacturers cited in the FDA’s Safety Communication Letter that the FDA recommends to “Immediately transition away from using plastic syringes manufactured” by these manufactures… “[because of] potential quality and performance issues”. No Sol-Millennium products are manufactured by either company.
Sol-Millennium puts product safety and reliability as its top priority. Our devices undergo rigorous design and development processes to ensure they meet globally recognized ISO standards including ISO 7886-1:2017, ISO 7886-2:2020, ISO8537:2016, ISO 7864:2016, and ISO 9626:2016 for their medical device portfolio.
For more information, please contact Sol-Millennium at info@sol-m.com.