Sol-Millennium Medical recalls syringes with exchangeable needles labeled SOL-CARE that were found by FDA to be substantially different from cleared 510(k)s with a major change in intended use. Affected models include various 1ml and 3ml syringes with specific UPCs and lot numbers.
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 is recalling syringes with exchangeable needles labeled SOL-CARE because they were found by the FDA to be substantially different from the current cleared 510(k) devices with a major change in intended use. This recall affects specific models and lot numbers of syringes sold with safety needles.
The FDA determined that the recalled syringes are substantially different from the current cleared 510(k) devices with a major change in intended use. This means the syringes may not function as intended for medical purposes, potentially leading to improper administration of medication.
Users of the SOL-CARE syringes with exchangeable needles labeled as 1ml or 3ml Luer Lock syringes with safety needles are most at risk. The recall includes specific model numbers and lot numbers listed in the notice.
Check for syringes labeled SOL-CARE with specific model numbers and UPCs listed in the recall notice. The affected models include 1ml and 3ml Luer Lock syringes with safety needles, such as Model No. 102115SN, 102215SN, and others.
Identify your syringe model and lot numbers by checking the label for SOL-CARE syringes with specific model numbers and UPCs listed in the recall notice.
The FDA found that these syringes are substantially different from the current cleared 510(k) devices with a major change in intended use.
Affected models include SOL-CARE 1ml and 3ml Luer Lock syringes with safety needles, such as Model No. 102115SN, 102215SN, 12510SN, and others with specific UPCs and lot numbers.
The recall notice does not specify a remedy, so you should check the product details to see if it is affected and contact the manufacturer for further instructions.
We’ve drafted a message you can send Sol-Millennium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3075-2024 — Sol-Millennium Medical Sol-Millennium Medical Hello, I own a Sol-Millennium Medical that is covered by recall Z-3075-2024 from Sol-Millennium Medical. 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.
