Unomedical A/S: VariSoft Infusion Sets Recalled for Packaging Error and Incorrect Brand Labeling

Agency Publication Date: September 19, 2024

Summary

Unomedical A/S is recalling specific VariSoft Infusion Sets because they were packaged in secondary boxes incorrectly labeled as "Trusteel Infusion Set." This labeling error means the external box does not match the actual medical device inside, which could lead to the use of an incorrect infusion set for insulin delivery. Consumers should contact their healthcare provider or the manufacturer regarding the affected units distributed in California.

Risk

The use of an incorrect infusion set due to mismatched packaging may lead to improper insulin delivery or site complications. While no specific injuries were reported in this notice, using a device different from what was prescribed or expected can result in poor glucose management.

What You Should Do

Check your infusion set boxes to see if they are labeled as 'Trusteel Infusion Set' but contain VariSoft Infusion Sets inside.
Verify the product identification by looking for Product Code 1726035 and Lot Number 6005241 on the packaging.
Confirm if the UDI-DI on your product matches 05705244018747.
Contact your healthcare provider to discuss whether the device you have is appropriate for your medical needs or if a replacement is required.
Contact Unomedical A/S or your distributor for further instructions regarding the return or replacement of these incorrectly labeled boxes.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VariSoft Infusion Set, Single Use

Model / REF:

1726035

UPC Codes:

05705244018747

Lot Numbers:

6005241

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95224

Status: Active

Manufacturer: Unomedical A/S

Sold By: Osted

Manufactured In: Denmark

Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your infusion set boxes to see if they are labeled as 'Trusteel Infusion Set' but contain VariSoft Infusion Sets inside.

Verify the product identification by looking for Product Code 1726035 and Lot Number 6005241 on the packaging.

Confirm if the UDI-DI on your product matches 05705244018747.

Contact your healthcare provider to discuss whether the device you have is appropriate for your medical needs or if a replacement is required.

Contact Unomedical A/S or your distributor for further instructions regarding the return or replacement of these incorrectly labeled boxes.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.