Reported Sep 18, 2024 · Ongoing
Syringes with exchangeable needles labeled as
Sol-Millennium Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sol-Millennium Medical Inc. · 311 S Wacker Dr · Chicago, IL · 60606-6604
Is this the product you have?
a) SOL-M
46 of 46 products
| Model / number | Barcodes | Product as published |
|---|---|---|
818392010268 | Model No. 1812010, , Lot Numbers: 4202007 | |
818392010275 | Model No. 1812015, , Lot Numbers: 4110010 | |
818392010244 | Model No. 1812110, , Lot Numbers: 4202008 | |
818392010251 | Model No. 1812115, , Lot Numbers: 2108094, 4110087, 4110088, 4303013, 4303015, 4304027, 4311001, 4312014, 4312022 | |
818392010237 | Model No. 1812210, , Lot Numbers: 4302040 | |
818392011586 | Model No. 1832010, , Lot Numbers: 4110005 | |
818392010114 | Model No. 1832015, , Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021, 4110005 | |
818392010084 | Model No. 1832110, , Lot Numbers: 5105119, 19041740 | |
818392010091 | Model No. 1832115, , Lot Numbers: 4106053, 4202035, 4306035 | |
818392010039 | Model No. 1832210, , Lot Numbers: 4110006, 4209012 | |
818392010077 | Model No. 1832215, , Lot Numbers: 4102053, 4106153, 4202003, 4202003, 4306034, 4307015, 4307043, 4308047, 4309030, 4309040, 4310033 | |
818392010107 | Model No. 1832310, , Lot Numbers: 4102058, 4102059, 4103020, 4103021, 4103028, 4103029, 4106048, 4106049, 4106052, 4110007, 4110053, 1902183, 19021824 | |
818392010053 | Model No. 1832510, , Lot Numbers: 4012001, 4102056, 4103014, 4103015, 4103022, 4103023, 4103030, 4103031, 4106050, 4106051, 4109091, 19021825, 19021826, 19041742 | |
818392010046 | Model No. 1832515, , Lot Numbers: 4012002, 4102054, 4103018, 4103019 | |
818392010022 | Model No. 1832558, , Lot Numbers: 4007045, 40 10033, 4102050, 4102051, 4102052, 4103016, 4103017, 4110011, 4110012 | |
818392010190 | Model No. 1852010, , Lot Numbers: EXPIRED | |
818392010206 | Model No. 1852015, , Lot Numbers: EXPIRED | |
818392010183 | Model No. 1852115, , Lot Numbers: 4103076, 4105110 | |
818392010169 | Model No. 1852215, , Lot Numbers: 4001001, 4003019, 4110083, 4110084, 4202004, 4308046, 4308088, 4312097, 19052010 | |
818392014341 | 110101120011 | Model No. 110101120011, , Lot Numbers: 4212007, 4306027, 4308066, 19030602 |
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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