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All product recalls associated with Unomedical A/S Aaholmvej.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Oct 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
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.