FDA recalls Sol-Millennium Syringes with Luer Slip Tips due to being substantially different from cleared 510(k)s. Affected models include 1ml, 20ml, 3ml, 5ml, 10ml, 30ml, and 60ml syringes without needles. Check model numbers and lot numbers for affected items.
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 syringes with Luer Slip Tips that were found by the FDA to differ significantly from their approved medical device designs. This recall affects specific model numbers and lot numbers for syringes ranging from 1ml to 60ml without needles. Using these syringes could pose risks due to unintended changes in how they're intended to be used.
The FDA determined that the syringes were substantially different from the current cleared 510(k) designs, indicating a major change or modification to the device's intended use. This could lead to improper function or safety issues if the syringes are used as intended without the necessary design features.
Users of Sol-Millennium syringes with Luer Slip Tips, particularly those who have purchased the affected model numbers and lot numbers listed in the recall notice. Healthcare professionals and patients using these syringes for medical purposes are most at risk.
Check for syringes labeled as SOL-M 1ml, 20ml, 3ml, 5ml, 10ml, 30ml, or 60ml with Luer Slip Tips without needles. Look for model numbers like 180011, P180011, 180020ST, P180003ST, P180005ST, P180010ST, P180020ST, P180030ST, P180060ST, or P180011T and corresponding lot numbers listed in the recall notice.
Identify your syringe model number and lot number by checking the product label or packaging.
The FDA found that these syringes were substantially different from the current cleared 510(k) designs, indicating a major change or modification to the device's intended use.
Affected models include SOL-M 1ml, 20ml, 3ml, 5ml, 10ml, 30ml, and 60ml syringes with Luer Slip Tips without needles, specifically model numbers 180011, P180011, 180020ST, P180003ST, P180005ST, P180010ST, P180020ST, P180030ST, P180060ST, and P180011T.
The recall notice does not specify a remedy, so you should check the product label for model and lot numbers and contact Sol-Millennium Medical Inc. for further instructions.
We’ve drafted a message you can send Sol-Millennium to request your refund or repair — edit it as you like.
Subject: Recall Z-3076-2024 — Sol-Millennium Sol-Millennium Hello, I own a Sol-Millennium that is covered by recall Z-3076-2024 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.
