SOL-M Syringes with eccentric tips recalled for regulatory non-compliance
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical devices with substantial deviations from cleared 510(k) specifications and major modifications to intended use. While no injuries or illnesses have been reported, syringes are risk-of-harm medical devices, and regulatory non-compliance poses potential safety concerns.
Plain-English summary
Sol-Millennium Medical Inc. is recalling SOL-M Syringes with Eccentric Tips in three models: 10ml (Model P180010ET), 20ml (Model P180020ET), and 60ml (Model P180060ET). The FDA found that these syringes in distribution differ substantially from the specifications in the current cleared 510(k) submissions, with major changes to the device's intended use.
The affected products have been distributed throughout the United States and internationally to countries including Canada, UK, Australia, and many others. Specific lot numbers affected include 4209010 (10ml model), 4209011 (20ml and 60ml models), and 4209009 (60ml model).
Medical devices must be manufactured according to their FDA-cleared specifications. Modifications to a device's design or intended use without proper FDA review and approval create potential risks to patient safety. Healthcare facilities and individuals who have received these syringes should stop using them and contact Sol-Millennium Medical Inc. or the FDA for information on proper disposal or replacement.
The recalled product
- Product
- Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P
- Manufacturer
- Sol-Millennium Medical Inc.
- Hazard
- regulatory-non-compliance
- device-modification
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 1) Model No. P180010ET
- Lot Numbers: 4209010
- 2) Model No. P180020ET
- Lot Numbers: 4209011
- 3) Model No. P180060ET
- Lot Numbers: 4209009
- 4209011
Distribution
Distributed nationwide across the United States.
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