Sol-Millennium Medical Inc. recalls three syringe models with eccentric tips due to FDA finding they differ substantially from cleared 510(k)s. Affected units include specific models and lot numbers. Consumers should contact the company for details.
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.
Sol-Millennium Medical Inc. is recalling three syringe models with eccentric tips because the FDA found they are substantially different from the cleared 510(k) standards. This could affect safety if used as intended. Consumers should check their syringes against the listed models and lot numbers.
The FDA determined that these syringes differ substantially from the cleared 510(k) standards, which means they may not function as intended. This could lead to improper use or safety issues if the syringes are used without the necessary modifications.
People who own or use the recalled syringes with eccentric tips, particularly those in medical settings requiring precise injections. Medical professionals and patients using these syringes are at higher risk.
Check for syringes labeled as SOL-M 10ml, 20ml, or 60ml with eccentric tips without needles. Model numbers P180010ET, P180020ET, or P180060ET with specific lot numbers (4209010, 4209011, or 4209009) are affected.
Identify if your syringe matches the model numbers and lot numbers listed in the recall notice.
The FDA found that these syringes differ substantially from the cleared 510(k) standards, which could affect their intended use and safety.
Syringes with model numbers P180010ET (10ml), P180020ET (20ml), and P180060ET (60ml) with specific lot numbers.
The recall does not specify a stop-use instruction, so you should check if your syringe matches the affected models before deciding.
We’ve drafted a message you can send Sol-Millennium to request your refund or repair — edit it as you like.
Subject: Recall Z-3077-2024 — Sol-Millennium Sol-Millennium Hello, I own a Sol-Millennium that is covered by recall Z-3077-2024 from Sol-Millennium. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
