Unomedical A/S 2024-04-24 Health serious FDA
Health · FDA · Recall #FDA-Z-1544-2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set Recall
Issued April 24, 2024 · Unomedical A/S
In April 2024, Unomedical A/S recalled the Neria Soft Infusion Set, Product Code 507302, intravascular administration set, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
What you should do
- 1 Stop using Neria Soft Infusion Set, Product Code 507302, intravascular administration set right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Unomedical A/S 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
- Unomedical A/S
- Category
- Health
- Recall date
- April 24, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of Florida.
- Recall number
- FDA-Z-1544-2024
- Made in
- Denmark
- Issuing agency
- FDA
In context
- Unomedical A/S has 2 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.