VariSoft infusion set, Model Number 1002827
- Company
- Unomedical A/S Aaholmvej
- Recall Initiated
- October 11, 2023
- Posted
- November 21, 2023
- Recall Number
- Z-0232-2024
- Quantity
- 8028 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of CA.
Lot / Code Info
GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366
Root Cause
Process change control
Action Taken
Unomedical a/s issued an Urgent Field Safety Notice to its sole consignee on 10/11/2023 via email. The notice explained the issue, potential risk to patient, and requested the distributor to quarantine all affected product pending return and to notify their customers.