Experience the future of insulin administration at Sol-Millennium’s booth!

Sol-Millennium is gearing up to make a significant impact at the highly anticipated 2024 LCL/SDM Pharmacy and Wellness Exhibit Day Conferences, scheduled for June 1st in Toronto and June 14th in Calgary. Among the comprehensive portfolio of diabetes care products, Sol-Millennium is excited to introduce the InsuJet™. This device heralds a paradigm shift in insulin administration, eliminating the discomfort and fear associated with needles. For millions worldwide, fear of injections is a significant barrier to effective diabetes management. The InsuJet™ needle-free mechanism offers an alternative insulin delivery method without having a needle prick.

Come by and meet with our team for a live product demonstration. See you there!

June 1: Toronto Congress Centre South Building Halls F&G | Booth 419

June 14: Calgary TELUS Convention Centre North Building Halls C&D | Booth 222

Exploring Innovation: Evolving Diabetes Care

PharmaChoice is a Canadian cooperative network of independently owned and operated pharmacies with over 800 retail locations across Canada. Through their commitment to community health and wellness, PharmaChoice pharmacies play a vital role in supporting the healthcare needs of Canadians across the country. Sol-Millennium similarly echoes this commitment through its mission of building a healthier tomorrow, achieved through collaborative initiatives and innovative solutions.

From May 9th-13th, Sol-Millennium was excited to participate in the PharmaChoice conference at the Halifax Convention Centre in Halifax, Canada. At Sol-Millennium's booth, attendees were introduced to the InsuJet™, a needle-free insulin administration system, alongside a comprehensive portfolio of diabetes care products.

For more information, please visit SolM InsuJet

Sol-Millennium Highlights Innovation at Pharmasave National Conference in Ottawa

Pharmasave is a well-established pharmacy retail chain in Canada. Founded in 1981, Pharmasave has grown to become one of the most recognized pharmacy brands in the country, with over 800 retail stores across Canada. Sol-Millennium was thrilled to participate in the Pharmasave National Conference that took place from May 1-3, showcasing a comprehensive selection of diabetes care products. Among them, the InsuJet™ garnered significant attention for its innovative approach as a needle-free insulin delivery system.

Thank you, Pharmasave National, for having us!

For more information, please visit SolM InsuJet

Chicago, IL, May 8, 2024

Sol-Millennium is initiating a voluntary recall for low dead space (“LDS”) syringes, luer slip tip syringes, and “combined” syringes with needle and syringe components packaged together. These products were found by the FDA to be substantially different from our current cleared 510(k)s with a major change or modification to the device’s intended use without a 510(k) clearance that remain outside our control beyond the distributor level. The affected company SKUs are attached in Appendix A. 

The products identified in this voluntary recall do not impact customers outside of the US.

This recall action has been identified due to the U.S. Food and Drug Administration’s (“FDA”) determination that these devices require 510(k) clearance, as the absence of FDA review to appropriately verify and validate the changes could lead to adverse health consequences.  We ask that: 

1. Combined products beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submissions. 

2. LDS products beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission. 

3. Luer Slip Tip Syringes beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission. 

4. Eccentric Tip Syringes beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission. 

5. Accessories be field destroyed.  

Sol-Millennium is working with the FDA to submit the applicable 510(k)s and will keep customers updated on the status. Affected products will become available once the 510(k) clearance is granted.  

Sol-Millennium will be notifying its distributors and customers, the lot specific information and  further instructions pertaining to the voluntary recall via electronic communications and letter.  This recall action is being executed with the knowledge of the US Food and Drug Administration.  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, regular mail or by fax. 

If you have any questions, please contact recalls@sol-m.com or call 1-833-637-0857. 

We thank you for your patience and understanding.  

Wholehealth Pharmacy Partners 200th Gala Celebration

Chris Jarvis, a former Canadian Olympic rower and the founder of I Challenge Diabetes, was a guest speaker at the Whole Health Pharmacy Partners Conference on April 19th, 2024. Having lived with type 1 diabetes for over 25 years, Chris introduced the groundbreaking needle-free insulin delivery device, the InsuJet™. Joining him at the event was Daphne Lapenna, Sol-Millennium's National Key Account Manager, who demonstrated this cutting-edge device at the Wholehealth booth.

The opportunity to witness the future of insulin administration was not to be missed!

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.

‍

We look forward to seeing you again in the Spring!

For over three decades, ILDA has served as a premier platform fostering networking, education, and collaboration within the independent laboratory distributors' community. Sol-Millennium eagerly anticipated continued membership in 2024 with ILDA, which included participation in their Spring and upcoming Fall meetings. The 2024 Spring Conference took place from April 14th to 16th in Philadelphia, Pennsylvania.

‍