Sol-Millennium Medical Inc. 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; Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
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;
Brand
Sol-Millennium Medical Inc.
Lot Codes / Batch Numbers
Model No. 181025, UPC 818392014884, Lot Numbers: 4302039, 4308074, 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593, Lot Numbers: 4103001, 4106151, 4111045, 4304001, 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609, Lot Numbers: 4103001, 4106151, 4111045, 4304001, 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616, Lot Numbers: 4103001, 4106151, 4111045, 4304001, b) SOL-CARE: 1) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1'', Model No. 12310SN, UPC 810018098148, Lot Numbers: 4108032, 7107049, 2) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1 1/2'', Model No. 12315SN, UPC 810018098827, Lot Numbers: 4110077, 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 12515SN, UPC 810018098155, Lot Numbers: 4108033, 7107048, 4) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 32515SN, UPC 810018098162, Lot Numbers: 4108034, 4109052, c) MEDLINE: 1) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS101235F, UPC 10888277222298, Lot Numbers: 1008006, 1011003, 1011012, 1103028, 1105073, 1909004, 1910005, 1910037, 1911016, 19061701, 2) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS101255F, UPC 10888277222472, Lot Numbers: 1009007, 1009014, 1011013, 1011023, 1102018, 1105074, 1910038, 1911017, 1912007, 3) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. SYRS101272F, UPC 10888277222489, Lot Numbers: 1001014, 1001016, 1009006, 1010004, 1012006, 19041693, 19052315, 19061702, 19071701, 4) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. SYRS101392F, UPC 10888277222502, Lot Numbers: 1009041, 1103029, 1109049, 1110059, 1111051, 5) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. SYRS103205, UPC 10888277222519, Lot Numbers: 1003008, 1009015, 1011014, 1011024, 1012010, 1912008, 19041694, 6) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS103207, UPC 10888277222526, Lot Numbers: 1102013, 1103030, 1105052, 7) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1, Model No. SYRS103215, UPC 10888277222533, Lot Numbers: 1007004, 1012007, 1101011, 1102019, 1104037, 1909007, 1910033, 1912009, 19040902, 8) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS103217, UPC 10888277222540, Lot Numbers: 1001020, 1010005, 1012008, 1104038, 1912010, 19072630, 9) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. SYRS103225, UPC 10888277222557, Lot Numbers: 1008007, 1009004, 1010002, 1012004, 1101010, 1102014, 1104039, 1105053, 1105075, 1909005, 1910006, 1910034, 1910039, 1911018, 19071702, 10) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS103227, UPC 10888277222564, Lot Numbers: 1001017, 1004041, 1009005, 1009016, 1010003, 1011015, 1011025, 1012005, 1102015, 1102020, 1909008, 1910035, 1910040, 1911019, 19040901, 11) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS103235, UPC 10888277222571, Lot Numbers: 1004040, 1006027, 1007001, 1007005, 1008020, 1008022, 1009001, 1010001, 1011005, 1011016, 1011026, 1011026, 1012001, 1102011, 1102016, 1102021, 1103024, 1105045, 1105054, 1105076, 1911020, 1912011, 19040903, 19052316, 19071703, 19072631, 12) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. SYRS103253, UPC 10888277222588, Lot Numbers: 1007002, 1007006, 1009002, 1012002, 1101009, 1102022, 1103031, 1104040, 1105055, 1105077, 1911021, 19052317, 19072632, 13) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS103255, UPC 10888277222595, Lot Numbers: 1007007, 1008008, 1008021, 1008023, 1009003, 1010001, 1011006, 1011017, 1011027, 1012003, 1101006, 1102012, 1102017, 1102023, 1103023, 1910007, 1910036, 1911022, 19072633, 14) MEDLINE 5ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS105217, UPC 10888277222632, Lot Numbers: 1003009, 1011004, 1101008, 1910041, 19041695, 15) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS110207, UPC 10888277222670, Lot Numbers: 1009017, 1101007, 16) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS110217, UPC 10888277222694, Lot Numbers: 1003010, 1012009, 1104041, 19051518, 19072640, 17) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS110227, UPC 10888277222892, Lot Numbers: 1001019, 1105078, 1909006, 1910042, 19072635, d) MONOJECT: 1) MONOJECT 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11812558, UPC 1092253025132, Lot Numbers: 1004002, 1004039, 1006001, 1012017, 1102039, 1103012, 1104002, 1107027, 1108027, 1108031, 1108046, 1205005, 1210005, 1301022, 1308036, 1310021, 1312020, 2) MONOJECT 1ml Syringe w/Hypodermic Safety Needle 27G*1/2, Model No. 11812705, UPC 10192253025149, Lot Numbers: 1008024, 1012018, 1103013, 1104003, 1104016, 1107028, 1108028, 1108032, 1108051, 1910016, 3) MONOJECT 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. 11813005, UPC 10192253025156, Lot Numbers: 1012024, 1211001, 4) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. 11832010, UPC 10192253025163, Lot Numbers: 1107029, 1108047, 5) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. 11832015, UPC 10192253025170, Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021, 6) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 21G*1, Model No. 11832110, UPC 10192253025187, Lot Numbers: 1108033, 1108048, 1110066, 1111052, 1112020, 1112055, 1910017, 7) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 11832115, UPC 10192253025194, Lot Numbers: 1107030, 1108029, 1108034, 1108049, 1304019, 1305008, 1310004, 8) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 22G*1, Model No. 11832210, UPC 10192253025200, Lot Numbers: 1010017, 1012012, 1012020, 1110068, 1112022, 1201008, 1203020, 1302007, 1304018, 1305009, 1312021, 1910018, 9) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 11832215, UPC 10192253025217, Lot Numbers: 1010018, 1012013, 1012021, 1102036, 1107031, 1305010, 1306008, 1310005, 1312022, 10) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 11832310, UPC 10192253025224, Lot Numbers: 1006002, 1010007, 1010009, 1010019, 1011007, 1011008, 1011009, 1011010, 1011011, 1012014, 1012022, 1102037, 1103011, 1104001, 1104017, 1104018, 1104019, 1104020, 1104021, 1108034, 1910019, 11) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1 1/2, Model No. 11832315, UPC 10192253025231, Lot Numbers: 1010020, 1012015, 1012023, 1102038, 1104022, 1105001, 12) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 11832510, UPC 10192253025248, Lot Numbers: 1012016, 1102040, 1103014, 1104004, 1105002, 1105003, 1108030, 1108050, 1910020, 13) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11832558, UPC 10192253025225, Lot Numbers: 1012025, 1102041, 1103015, 1104005, 1105004, 1107032, 1108036, 1108052, e) HENRY SCHEIN: 1) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 900-7640, UPC 10304040017057, Lot Numbers: 1003005, 1011037, 1102053, 1106079, 1307004, 1910010, 1911033, 2) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. 900-7641, UPC 10304040017064, Lot Numbers: 1003007, 1011038, 1101004, 1102054, 1110060, 1211003, 1303004, 1307006, 1910008, 1911034, 3) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 900-7642, UPC 10304040017071, Lot Numbers: 110608, 1003006, 1011039, 1101005, 1106080, 1303003, 1304013, 1307007, 1910011, 1911035, 19042613, 4) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 900-7643, UPC 10304040017088, Lot Numbers: 1001003, 1009036, 1011040.1012042, 1103022, 1106081, 1108057, 1112054, 1203021, 1307005, 1910009, 1911003, 1912001, 19042614, 19072303, 5) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7644, UPC 10304040017095, Lot Numbers: 191008, 1006016, 1009037, 1010006, 1011054, 1011062, 1104061, 1104063, 1105025, 1105027, 1105029, 1105031, 1105033, 1105035, 1105037, 1106082, 1108056, 1911008, 1911030, 6) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7645, UPC 10304040017101, Lot Numbers: 1008011, 1009035, 1012043, 1102051, 1106077, 1112053, 1202007, 1203015, 1911009, 1911036, 1912014, 19072304, 7) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7646, UPC 10304040017118, Lot Numbers: 1001021, 1008012, 1009039, 1101003, 1102056, 1104062, 1104064, 1105026, 1105028, 1105030, 1105032, 1105034, 1105036, 1105038, 1106084, 1309012, 1911032, 19042616, 8) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2, Model No. 900-7647, UPC 10304040017125, Lot Numbers: 1004001, 1102055, 1106083, 1911028, 9) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. 900-7648, UPC 10304040017149, Lot Numbers: 1009034, 1102052, 1106078, 1109046, 1211004, 1908010, 1911010, 1911029, 19042615, 10) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7663, UPC 10304040017194, Lot Numbers: 1001008, 1011041, 1102050, 1106076, 1911004
Products Sold
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, Lot Numbers: 4302039, 4308074; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593, Lot Numbers: 4103001, 4106151, 4111045, 4304001; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609, Lot Numbers: 4103001, 4106151, 4111045, 4304001; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616, Lot Numbers: 4103001, 4106151, 4111045, 4304001; b) SOL-CARE: 1) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1'', Model No. 12310SN, UPC 810018098148, Lot Numbers: 4108032, 7107049; 2) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1 1/2'', Model No. 12315SN, UPC 810018098827, Lot Numbers: 4110077; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 12515SN, UPC 810018098155, Lot Numbers: 4108033, 7107048; 4) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 32515SN, UPC 810018098162, Lot Numbers: 4108034, 4109052; c) MEDLINE: 1) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS101235F, UPC 10888277222298, Lot Numbers: 1008006, 1011003, 1011012, 1103028, 1105073, 1909004, 1910005, 1910037, 1911016, 19061701; 2) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS101255F, UPC 10888277222472, Lot Numbers: 1009007, 1009014, 1011013, 1011023, 1102018, 1105074, 1910038, 1911017, 1912007; 3) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. SYRS101272F, UPC 10888277222489, Lot Numbers: 1001014, 1001016, 1009006, 1010004, 1012006, 19041693, 19052315, 19061702, 19071701; 4) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. SYRS101392F, UPC 10888277222502, Lot Numbers: 1009041, 1103029, 1109049, 1110059, 1111051; 5) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. SYRS103205, UPC 10888277222519, Lot Numbers: 1003008, 1009015, 1011014, 1011024, 1012010, 1912008, 19041694; 6) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS103207, UPC 10888277222526, Lot Numbers: 1102013, 1103030, 1105052; 7) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1, Model No. SYRS103215, UPC 10888277222533, Lot Numbers: 1007004, 1012007, 1101011, 1102019, 1104037, 1909007, 1910033, 1912009, 19040902; 8) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS103217, UPC 10888277222540, Lot Numbers: 1001020, 1010005, 1012008, 1104038, 1912010, 19072630; 9) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. SYRS103225, UPC 10888277222557, Lot Numbers: 1008007, 1009004, 1010002, 1012004, 1101010, 1102014, 1104039, 1105053, 1105075, 1909005, 1910006, 1910034, 1910039, 1911018, 19071702; 10) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS103227, UPC 10888277222564, Lot Numbers: 1001017, 1004041, 1009005, 1009016, 1010003, 1011015, 1011025, 1012005, 1102015, 1102020, 1909008, 1910035, 1910040, 1911019, 19040901; 11) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS103235, UPC 10888277222571, Lot Numbers: 1004040, 1006027, 1007001, 1007005, 1008020, 1008022, 1009001, 1010001, 1011005, 1011016, 1011026, 1011026, 1012001, 1102011, 1102016, 1102021, 1103024, 1105045, 1105054, 1105076, 1911020, 1912011, 19040903, 19052316, 19071703, 19072631; 12) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. SYRS103253, UPC 10888277222588, Lot Numbers: 1007002, 1007006, 1009002, 1012002, 1101009, 1102022, 1103031, 1104040, 1105055, 1105077, 1911021, 19052317, 19072632; 13) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS103255, UPC 10888277222595, Lot Numbers: 1007007, 1008008, 1008021, 1008023, 1009003, 1010001, 1011006, 1011017, 1011027, 1012003, 1101006, 1102012, 1102017, 1102023, 1103023, 1910007, 1910036, 1911022, 19072633; 14) MEDLINE 5ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS105217, UPC 10888277222632, Lot Numbers: 1003009, 1011004, 1101008, 1910041, 19041695; 15) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS110207, UPC 10888277222670, Lot Numbers: 1009017, 1101007; 16) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS110217, UPC 10888277222694, Lot Numbers: 1003010, 1012009, 1104041, 19051518, 19072640; 17) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS110227, UPC 10888277222892, Lot Numbers: 1001019, 1105078, 1909006, 1910042, 19072635; d) MONOJECT: 1) MONOJECT 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11812558, UPC 1092253025132, Lot Numbers: 1004002, 1004039, 1006001, 1012017, 1102039, 1103012, 1104002, 1107027, 1108027, 1108031, 1108046, 1205005, 1210005, 1301022, 1308036, 1310021, 1312020; 2) MONOJECT 1ml Syringe w/Hypodermic Safety Needle 27G*1/2, Model No. 11812705, UPC 10192253025149, Lot Numbers: 1008024, 1012018, 1103013, 1104003, 1104016, 1107028, 1108028, 1108032, 1108051, 1910016; 3) MONOJECT 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. 11813005, UPC 10192253025156, Lot Numbers: 1012024, 1211001; 4) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. 11832010, UPC 10192253025163, Lot Numbers: 1107029, 1108047; 5) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. 11832015, UPC 10192253025170, Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021; 6) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 21G*1, Model No. 11832110, UPC 10192253025187, Lot Numbers: 1108033, 1108048, 1110066, 1111052, 1112020, 1112055, 1910017; 7) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 11832115, UPC 10192253025194, Lot Numbers: 1107030, 1108029, 1108034, 1108049, 1304019, 1305008, 1310004; 8) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 22G*1, Model No. 11832210, UPC 10192253025200, Lot Numbers: 1010017, 1012012, 1012020, 1110068, 1112022, 1201008, 1203020, 1302007, 1304018, 1305009, 1312021, 1910018; 9) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 11832215, UPC 10192253025217, Lot Numbers: 1010018, 1012013, 1012021, 1102036, 1107031, 1305010, 1306008, 1310005, 1312022; 10) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 11832310, UPC 10192253025224, Lot Numbers: 1006002, 1010007, 1010009, 1010019, 1011007, 1011008, 1011009, 1011010, 1011011, 1012014, 1012022, 1102037, 1103011, 1104001, 1104017, 1104018, 1104019, 1104020, 1104021, 1108034, 1910019; 11) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1 1/2, Model No. 11832315, UPC 10192253025231, Lot Numbers: 1010020, 1012015, 1012023, 1102038, 1104022, 1105001; 12) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 11832510, UPC 10192253025248, Lot Numbers: 1012016, 1102040, 1103014, 1104004, 1105002, 1105003, 1108030, 1108050, 1910020; 13) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11832558, UPC 10192253025225, Lot Numbers: 1012025, 1102041, 1103015, 1104005, 1105004, 1107032, 1108036, 1108052; e) HENRY SCHEIN: 1) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 900-7640, UPC 10304040017057, Lot Numbers: 1003005, 1011037, 1102053, 1106079, 1307004, 1910010, 1911033; 2) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. 900-7641, UPC 10304040017064, Lot Numbers: 1003007, 1011038, 1101004, 1102054, 1110060, 1211003, 1303004, 1307006, 1910008, 1911034; 3) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 900-7642, UPC 10304040017071, Lot Numbers: 110608, 1003006, 1011039, 1101005, 1106080, 1303003, 1304013, 1307007, 1910011, 1911035, 19042613; 4) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 900-7643, UPC 10304040017088, Lot Numbers: 1001003, 1009036, 1011040.1012042, 1103022, 1106081, 1108057, 1112054, 1203021, 1307005, 1910009, 1911003, 1912001, 19042614, 19072303; 5) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7644, UPC 10304040017095, Lot Numbers: 191008, 1006016, 1009037, 1010006, 1011054, 1011062, 1104061, 1104063, 1105025, 1105027, 1105029, 1105031, 1105033, 1105035, 1105037, 1106082, 1108056, 1911008, 1911030; 6) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7645, UPC 10304040017101, Lot Numbers: 1008011, 1009035, 1012043, 1102051, 1106077, 1112053, 1202007, 1203015, 1911009, 1911036, 1912014, 19072304; 7) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7646, UPC 10304040017118, Lot Numbers: 1001021, 1008012, 1009039, 1101003, 1102056, 1104062, 1104064, 1105026, 1105028, 1105030, 1105032, 1105034, 1105036, 1105038, 1106084, 1309012, 1911032, 19042616; 8) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2, Model No. 900-7647, UPC 10304040017125, Lot Numbers: 1004001, 1102055, 1106083, 1911028; 9) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. 900-7648, UPC 10304040017149, Lot Numbers: 1009034, 1102052, 1106078, 1109046, 1211004, 1908010, 1911010, 1911029, 19042615; 10) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7663, UPC 10304040017194, Lot Numbers: 1001008, 1011041, 1102050, 1106076, 1911004
Sol-Millennium Medical Inc. is recalling Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8' due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Sol M issued a Voluntary Recall Action Letter to Distributors to its consignees on 05/09/2024 via email. The notice explained the reason for the recall and requested the following: "ACTIONS REQUIRED: 1. Examine your inventory and quarantine the affected product codes and lots subject to this recall action. 2. Distributors, please identify your customers, and notify them at once of this recall action to the distributor level. Such notification may be enhanced by including the enclosed letter (Appendix B) for your customers and Healthcare Providers (HCP s) in the field. 3. Return the enclosed Appendix B with the information via email to recalls@sol-m.com. The quarantine should be carried out to the wholesale and distributor level. Products in the field beyond the control of the distributor or wholesaler should be recalled from the field and returned to the distributor. Distributors should quarantine the products in inventory and quarantine the products received from customers until the 510(k) submissions are pending or cleared. The returned product should be quarantined in a secure location to avoid distribution based on your quality management procedures. We will provide communication with any updates as we work with the FDA."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026