Sol-Millennium Medical Inc.: 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;

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.

Details from the source

Reason for recall: 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. Distribution: 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 Lot/code info: a) SOL-M: 1) Model No. 1812010, UPC 818392010268, Lot Numbers: 4202007; 2) Model No. 1812015, UPC 818392010275, Lot Numbers: 4110010; 3) Model No. 1812110, UPC 818392010244, Lot Numbers: 4202008; 4) Model No. 1812115, UPC 818392010251, Lot Numbers: 2108094, 4110087, 4110088, 4303013, 4303015, 4304027, 4311001, 4312014, 4312022; 5) Model No. 1812210, UPC 818392010237, Lot Numbers: 4302040; 6) Model No. 1832010, UPC 818392011586, Lot Numbers: 4110005; 7) Model No. 1832015, UPC 818392010114, Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021, 4110005; 8) Model No. 1832110, UPC 818392010084, Lot Numbers: 5105119, 19041740; 9) Model No. 1832115, UPC 818392010091, Lot Numbers: 4106053, 4202035, 4306035; 10) Model No. 1832210, UPC 818392010039, Lot Numbers: 4110006, 4209012; 11) Model No. 1832215, UPC 818392010077, Lot Numbers: 4102053, 4106153, 4202003, 4202003, 4306034, 4307015, 4307043, 4308047, 4309030, 4309040, 4310033; 12) Model No. 1832310, UPC 818392010107, Lot Numbers: 4102058, 4102059, 4103020, 4103021, 4103028, 4103029, 4106048, 4106049, 4106052, 4110007, 4110053, 1902183, 19021824; 13) Model No. 1832510, UPC 818392010053, Lot Numbers: 4012001, 4102056, 4103014, 4103015, 4103022, 4103023, 4103030, 4103031, 4106050, 4106051, 4109091, 19021825, 19021826, 19041742; 14) Model No. 1832515, UPC 818392010046, Lot Numbers: 4012002, 4102054, 4103018, 4103019; 15) Model No. 1832558, UPC 818392010022, Lot Numbers: 4007045, 40 10033, 4102050, 4102051, 4102052,

UPC codes

818392010268, 818392010275, 818392010244, 818392010251, 818392010237, 818392011586, 818392010114, 818392010084, 818392010091, 818392010039, 818392010077, 818392010107, 818392010053, 818392010046, 818392010022, 818392010190, 818392010206, 818392010183, 818392010169, 110101120011, 818392014341, 110101120012, 818392014358, 818392012880, 818392013061, 10818392013075, 818392013702, 818392013696, 818392019858, 818392019865, 818392018851, 818392018950, 818392018967, 818392018974, 818392019001, 818392019018, 818392019025, 818392019032, 818392019049, 818392019063

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.