Unomedical A/S recalls
2 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Unomedical A/S, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
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.
VariSoft infusion set, Model Number 1002828
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.