Recall Z-3074-2024 ยท FMF Syringe, Piston
Sol-Millennium Medical Inc.
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle
| Date | Sep 6, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| Reason | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| Root cause | Other |
| Action | Sol M issued a Voluntary Recall Action Letter to Distributors to its consignees on 05/09/2024 via email. The notice explained the reason for the recall and requested the following: "ACTIONS REQUIRED: 1. Examine your inventory and quarantine the affected product codes and lots subject to this recall action. 2. Distributors, please identify your customers, and notify them at once of this recall action to the distributor level. Such notification may be enhanced by including the enclosed letter (Appendix B) for your customers and Healthcare Providers (HCP s) in the field. 3. Return the enclose |
| Distribution | US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.