Unomedical recalls Neria Soft Infusion Sets (Product Code 507302) with incorrect US instructions. Affected lots may have safety risks due to missing US-specific use details.
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.
Unomedical is recalling specific lots of Neria Soft Infusion Sets (Product Code 507302) because they came with the wrong instructions for US use. This could lead to improper use if someone follows the international instructions instead of the US-specific ones.
The recalled sets include instructions for international use instead of US-specific instructions. This means healthcare workers might not know how to safely use the product in the US healthcare setting, potentially leading to incorrect administration.
Healthcare professionals using these infusion sets for medical treatments are most at risk. Patients receiving care with these sets could be affected if the instructions are misinterpreted.
Check for Product Code 507302 with Lot Numbers 5277396 or 5371146. The set includes instructions marked for the Rest of World (ROW) countries, not the US.
Look for the instruction manual labeled for the Rest of World (ROW) countries instead of US-specific instructions.
The recalled sets have instructions for international use instead of US-specific instructions, which could lead to improper use in the US healthcare setting.
The official recall notice does not specify a remedy, so check the instructions to ensure they are US-specific before use.
The recall indicates a potential risk of improper use due to missing US-specific instructions, but no specific injuries or deaths have been reported.
We’ve drafted a message you can send Unomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1544-2024 — Unomedical Unomedical Hello, I own a Unomedical that is covered by recall Z-1544-2024 from Unomedical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
