Unomedical A/S: VariSoft Infusion Sets Recalled Due to Risk of Detachment and High Blood Sugar

Agency Publication Date: November 21, 2023

Summary

Unomedical A/S has recalled 13,069 VariSoft infusion sets (Models 1002827, 1002828, and 1002830) used with Tandem insulin pumps because the connector piece may be damaged. This manufacturing defect allows the connector to detach too easily from the insulin set, which can stop insulin delivery without the user noticing. If this happens, especially during sleep, it can lead to dangerous elevations in blood sugar and ketone levels.

Risk

A detached connector prevents the pump from delivering necessary basal insulin, which can rapidly cause nocturnal hyperglycemia (high nighttime blood sugar) and diabetic ketoacidosis, a life-threatening medical emergency.

What You Should Do

Locate your VariSoft infusion set packaging and verify the Model Number and GTIN/Serial Number against the affected list. Affected models include Model 1002827 (GTIN 05705244018709 or 05705244018693), Model 1002828 (GTIN 05705244018730 or 05705244018723), and Model 1002830 (GTIN 05705244018792 or 05705244018785).
Check the serial numbers on your device packaging for the following codes: 5388357, 5388362, 5388372, 5388366, 5388367, 5388376, or 5388368.
If you identify an affected infusion set, contact your healthcare provider immediately to discuss alternative infusion options or monitoring protocols.
Contact the manufacturer, Unomedical A/S, or Tandem Diabetes Care for instructions on returning defective sets and obtaining replacements or potential refunds.
Monitor your blood glucose levels closely if you must continue using an infusion set until a replacement is available, and ensure all connections are secure.
For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

manufacturer or healthcare provider Consultation

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

Affected Products

Product: VariSoft infusion set

Model / REF:

1002827

UPC Codes:

05705244018709

05705244018693

Lot Numbers:

5388357

5388362

5388372

5388366

Product: VariSoft infusion set

Model / REF:

1002828

UPC Codes:

05705244018730

05705244018723

Lot Numbers:

5388367

5388376

Product: VariSoft infusion set

Model / REF:

1002830

UPC Codes:

05705244018792

05705244018785

Lot Numbers:

5388368

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93269

Status: Active

Manufacturer: Unomedical A/S

Sold By: Tandem Diabetes Care

Manufactured In: Denmark

Units Affected: 3 products (8028 units; 1679 units; 3362 units)

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

Locate your VariSoft infusion set packaging and verify the Model Number and GTIN/Serial Number against the affected list. Affected models include Model 1002827 (GTIN 05705244018709 or 05705244018693), Model 1002828 (GTIN 05705244018730 or 05705244018723), and Model 1002830 (GTIN 05705244018792 or 05705244018785).

Check the serial numbers on your device packaging for the following codes: 5388357, 5388362, 5388372, 5388366, 5388367, 5388376, or 5388368.

If you identify an affected infusion set, contact your healthcare provider immediately to discuss alternative infusion options or monitoring protocols.

Contact the manufacturer, Unomedical A/S, or Tandem Diabetes Care for instructions on returning defective sets and obtaining replacements or potential refunds.

Monitor your blood glucose levels closely if you must continue using an infusion set until a replacement is available, and ensure all connections are secure.

For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: VariSoft infusion set

Model / REF:

1002827

UPC Codes:

05705244018709

05705244018693

Lot Numbers:

5388357

5388362

5388372

5388366

Product: VariSoft infusion set

Model / REF:

1002828

UPC Codes:

05705244018730

05705244018723

Lot Numbers:

5388367

5388376

Product: VariSoft infusion set

Model / REF:

1002830

UPC Codes:

05705244018792

05705244018785

Lot Numbers:

5388368