On May 8th, 2024, Sol-Millennium initiated a voluntary recall for “combination” syringes with needle and syringe components packaged together, luer slip tip syringes, and low dead space (“LDS”) syringes.
As part of our commitment to ensure we have thoroughly corrected the underlying issues of the recalls, we committed to file the necessary 510(k) applications to bring our products in compliance with the current US-FDA regulatory requirements.
As of September 24th, 2024, US-FDA has granted Sol-M premarket clearance (510k: K241821) on the following families of devices:
- Standard Luer Lock Syringe with Safety Needle
- Standard Luer Lock Syringe with Blunt Fill Needle
- Standard Luer Lock Syringe with Exchangeable Needle
We have approval from the US-FDA to release the following item numbers from hold. Please ensure only the SKU’s below are released, and no others related to any Sol-Millennium Medical initiated recalls.
If you have any questions, please contact recalls@sol-m.com or call 1-833-637-0857.
Model Numbers Cleared by US-FDA under 510k K241821:
| Model No. | Description |
| 1812010 | SOL-M 10ml Luer Lock Syringe w/Exch Needle 20G*1” |
| 1812015 | SOL-M 10ml Luer Lock Syringe w/Exch Needle 20G*1 1/2” |
| 1812110 | SOL-M 10ml Luer Lock Syringe w/Exch Needle 21G*1” |
| 1812115 | SOL-M 10ml Luer Lock Syringe w/Exch Needle 21G*1 1/2” |
| 1812210 | SOL-M 10ml Luer Lock Syringe w/Exch Needle 22G*1” |
| 1832010 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 20G*1” |
| 1832015 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 20G*1 1/2” |
| 1832110 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 21G*1” |
| 1832115 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 21G*1 1/2” |
| 1832210 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 22G*1” |
| 1832215 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 22G*1 1/2” |
| 1832310 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 23G*1” |
| 1832510 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 25G*1” |
| 1832515 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 25G*1 1/2” |
| 1832558 | SOL-M 3ml Luer Lock Syringe w/Exch Needle 25G*5/8” |
| 1852010 | SOL-M 5ml Luer Lock Syringe w/Exch Needle 20G*1” |
| 1852015 | SOL-M 5ml Luer Lock Syringe w/Exch Needle 20G*1 1/2” |
| 1852115 | SOL-M 5ml Luer Lock Syringe w/Exch Needle 21G*1 1/2” |
| 1852215 | SOL-M 5ml Luer Lock Syringe w/Exch Needle 22G*1 1/2” |
| 110101120011 | SOL-M 10ml Luer Lock Syringe w/Exch Needle Tray 20G*1” |
| 110101120012 | SOL-M 10ml Luer Lock Syringe w/Exch Needle Tray 21G*1” |
| 102115SN | SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside) |
| 102215SN | SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside) |
| 1811815B | SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2” |
| 1831815B | SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2” |
| 1832110T | SOL-M 3ml Luer Lock Syringe w/Exch Needle Tray 21G*1” |
| 1832210T | SOL-M 3ml Luer Lock Syringe w/Exch Needle Tray 22G*1” |
| 1832310T | SOL-M 3ml Luer Lock Syringe w/Exch Needle Tray 23G*1” |
| 1851815B | SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2” |
| 1852010T | SOL-M 5ml Luer Lock Syringe w/Exch Needle Tray 20G*1” (sealed cap) |
| 1852110T | SOL-M 5ml Luer Lock Syringe w/Exch Needle Tray 21G*1” (sealed cap) |
| 32110SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside) |
| 32115SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside) |
| 32210SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside) |
| 32215SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside) |
| 32310SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside) |
| 32510SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside) |
| 32515SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2” |
| 32558SN | SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside) |
| 52115SN | SOL-CARE 5ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside) |
| 52215SN | SOL-CARE 5ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside) |
