Sol-Millennium Receives 510k Clearance on Syringe with Needle Combination Products

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)