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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
Recalled September 18, 2024 · FDA recall Z-3074-2024 · Sol-Millennium Medical
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. · FDA Class II
Sold at
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, Panama
Description
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.
Product
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 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
Manufacturer(s)
Sol-Millennium Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →