medical Class I Updated 2023-11-29

Unomedical A/S recalls VariSoft infusion set, Model Number 1002828

Recalled Product

VariSoft infusion set, Model Number 1002828


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →