Home / Brands / Unomedical A/S
Unomedical A/S Recalls
6 recalls on record · October 5, 2022 to September 25, 2024 · Medical Devices
Recalls by year
22
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 25, 2024Medical DevicesFDA
Unomedical A/S recalls VariSoft Infusion Set, Single Use.
Hazard: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
April 24, 2024Medical DevicesFDA
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Hazard: Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
November 29, 2023Medical DevicesFDA
Unomedical A/S recalls VariSoft infusion set, Model Number 1002830
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.
November 29, 2023Medical DevicesFDA
Unomedical A/S recalls VariSoft infusion set, Model Number 1002828
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.hyperglycemia). Diabetic ketoacidosis.
November 29, 2023Medical DevicesFDA
Unomedical A/S recalls VariSoft infusion set, Model Number 1002827
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.
October 5, 2022Medical DevicesFDA
Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusio
Hazard: The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.