Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead sp...
FDA Device Recall #Z-3078-2024 — Class II — May 9, 2024
Recall Summary
| Recall Number | Z-3078-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sol-Millennium Medical Inc. |
| Location | Chicago, IL |
| Product Type | Devices |
Product Description
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only
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 Pattern
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 Information
a) Model No. 180011LDS, UPC 840368511899, Lot Numbers: 1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401; b) Model No. P180011LDS, UPC 810018097554, Lot Numbers: 4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032; c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers: 4301029; d) Model No. 12558LDS, UPC 810062435319, Lot Numbers: 7210016; e) Model No. P180001PP, UPC 818392018165, Lot Numbers: 4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033; f) Model No. 181025S, UPC NONE, Lot Numbers: 4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,
Other Recalls from Sol-Millennium Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3077-2024 | Class II | Syringes with Eccentric Tips labeled as: 1) ... | May 9, 2024 |
| Z-3076-2024 | Class II | Syringes with Luer Slip Tips labeled as: 1) ... | May 9, 2024 |
| Z-3075-2024 | Class II | Syringes with exchangeable needles labeled as: ... | May 9, 2024 |
| Z-3074-2024 | Class II | Syringes with Fixed Needles labeled as: a) S... | May 9, 2024 |
| Z-3079-2024 | Class II | Syringe Tip Caps labeled as: 1) SOL-M Syring... | May 9, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.