Sol-Millennium Medical Inc. 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3077-2024
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o… Recall
Issued September 18, 2024 · Sol-Millennium Medical Inc.
In September 2024, Sol-Millennium Medical Inc. recalled the Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sol-Millennium Medical Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Sol-Millennium Medical Inc.
- Category
- Health
- Recall date
- September 18, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philipp
- Recall number
- FDA-Z-3077-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Sol-Millennium Medical Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.