Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VariSoft Infusion Set Recalled by Unomedical A/S Due to Specific VariSoftTM Infusion Sets were packaged using incorrect...

Date: July 23, 2024
Company: Unomedical A/S
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Unomedical A/S directly.

Affected Products

VariSoft Infusion Set, Single Use.

Why Was This Recalled?

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Unomedical A/S

Unomedical A/S has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report