Class II FDA device recall · Z-3075-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: Sol-Millennium Medical Inc.
Product type: Devices
Recall number: Z-3075-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Chicago, IL
Recall initiated: 2024-05-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-3075-2024 · Source: openFDA enforcement.