Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1

Summary

The FDA issued a Class II for Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml by Sol-Millennium Medical Inc.. Reason: 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.

Details

Product Description

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 Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

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, 4103016, 4103017, 4110011, 4110012; 16) Model No. 1852010, UPC 818392010190, Lot Numbers: EXPIRED 17) Model No. 1852015, UPC 818392010206, Lot Numbers: EXPIRED 18) Model No. 1852115, UPC 818392010183, Lot Numbers: 4103076, 4105110; 19) Model No. 1852215, UPC 818392010169, Lot Numbers: 4001001, 4003019, 4110083, 4110084, 4202004, 4308046, 4308088, 4312097, 19052010; 20) Model No. 110101120011, UPC 818392014341, Lot Numbers: 4212007, 4306027, 4308066, 19030602; 21) Model No. 110101120012, UPC 818392014358, Lot Numbers: 4001021, 4008151, 4104087, 4110036, 4202006, 19030603; 22) Model No. 1832110T, UPC 818392012880, Lot Numbers: 4103002, 4104043, 4105120, 4106152, 4109083, 4110045, 4111040, 4206041, 4206042, 4206043, 4208008, 4208009, 4208010, 4303041, 4304026, 4306046, 4308071, 4312018; 23) Model No. 1832210T, UPC 818392013061, Lot Numbers: 4110046, 4307048, 4308091; 24) Model No. 1832310T, UPC 10818392013075, Lot Numbers: 4110047; 25) Model No. 1852010T, UPC 818392013702, Lot Numbers: 4104083; 26) Model No. 1852110T, UPC 818392013696, Lot Numbers: 4005030, 4007049, 4103080, 4104084, 4105111, 4302024, 4308067, 4310031, 4312019, 4312102, 4912026, 19072314; b) SOL-CARE: 1) Model No. 102115SN, UPC 818392019858, Lot Numbers: 4104022; 2) Model No. 102215SN, UPC 818392019865, Lot Numbers: 4004004, 4303018, 4304057; 3) Model No. 12510SN, UPC 818392018851, Lot Numbers: 4108037, 7106031, 7109036; 4) Model No. 12558SN, UPC 818392018950, Lot Numbers: 4004005, 4104008, 4104011, 4104012, 4106034, 7107051, 7112016; 5) Model No. 12705SN, UPC 818392018967, Lot Numbers: 4004006, 7109007; 6) Model No. 13005SN, UPC 818392018974, Lot Numbers: 4004002; 7) Model No. 32110SN, UPC 818392019001, Lot Numbers: 4004031, 5101401; 8) Model No. 32115SN, UPC 818392019018, Lot Numbers: 4109051, 19072315; 9) Model No. 32210SN, UPC 818392019025, Lot Numbers: 4007046, 4301035, 4312117; 10) Model No. 32215SN, UPC 818392019032, Lot Numbers: 4301036; 11) Model No. 32310SN, UPC 818392019049, Lot Numbers: 3102005, 4004031, 4104013, 4107091, 4108035, 5104011, 5104012; 12) Model No. 32510SN, UPC 818392019063, Lot Numbers: 4007047, 4007051, 4104009, 4105096, 4105100, 4108031, 4108032, 4108036, 7111006; 13) Model No. 32558SN, UPC 818392019070, Lot Numbers: 4007048, 4007052, 4104010, 4104018; 14) Model No. 52115SN, UPC 818392018912, Lot Numbers: 4110017, 4309051; 15) Model No. 52215SN, UPC 818392018936, Lot Numbers: 4004003, 4107173; c) HENRY SCHEIN: 1) Model No. 900-7842, UPC 10304040017200, Lot Numbers: 1012089, 1012091, 1102061, 1103043, 1103044, 1103045, 1103046, 2111063, 2111064, 2203033, 2209013, 2211025, 2211026, 2307003, 2307094, 2309046, 4005032, 4005054, 4007040, 4007041; 2) Model No. 900-7843, UPC 10304040017217, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007; 3) Model No. 900-7844, UPC 10304040017224, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-05-09

Company