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Sol-Millennium Medical Recalls
6 recalls on record · September 18, 2024 to September 18, 2024 · Medical Devices
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, R
Hazard: 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.
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011L
Hazard: 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.
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 810
Hazard: 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.
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 818392301013
Hazard: 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.
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1
Hazard: 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.
September 18, 2024Medical DevicesFDA
Sol-Millennium Medical Inc. recalls Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 18102
Hazard: 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.