Sol-Millennium Medical Inc. Recalls

6 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (6)

May 9, 2024
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
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.
Class II
May 9, 2024
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N
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.
Class II
May 9, 2024
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Lue
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.
Class II
May 9, 2024
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET,
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.
Class II
May 9, 2024
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 8100180975
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.
Class II
May 9, 2024
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space
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.
Class II

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