Reported Sep 18, 2024 · Ongoing
Syringes with Low Dead Space 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?
Syringes with Low Dead Space labeled as
6 of 6 products
| Model / number | Product as published |
|---|---|
840368511899 | SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS |
810018097554 | SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS |
181023L | SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), , UPC Sold in Canada Only |
810062435319 | SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS |
818392018165 | SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP |
181025S | SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), , UPC Sold in Canada Only |
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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