Sol-Millennium Issues Voluntary Recall of Low Dead Space Syringes, Luer Slip Tip Syringes, Syringes with Needle and Syringe Components Packaged Together (US only)
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:
Combined products beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submissions.
LDS products beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission.
Luer Slip Tip Syringes beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission.
Eccentric Tip Syringes beyond the distribution level be returned and quarantined at the distributor, pending clearance of our 510(k) premarket submission.
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.
