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Unomedical A/S recalls VariSoft infusion set, Model Number 1002827
Recalled November 29, 2023 · FDA recall Z-0232-2024 · Unomedical A/S
Hazard
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. · FDA Class I
Units
8028 units
Sold at
US Nationwide distribution in the state of CA.
Description
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.
Product
VariSoft infusion set, Model Number 1002827
Manufacturer(s)
Unomedical A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →