Official recall record

VariSoft infusion set, Model Number 1002828

US FDA — Medical Devices · 2023-10-11 · DenmarkClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-10-11
Country of alert: Denmark
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 05705244018730
Brand on record: Unomedical A/S

What the authority reported

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Denmark · all filters

Other recalls from this brand

2024-03-05 · US FDA — Medical Devices
Neria Soft Infusion Set, Product Code 507302, intravascular administration set

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.