Unomedical A/S Recall 93269
Description: VariSoft infusion set, Model Number 1002828
Unomedical A/S Recall 93269 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0233-2024 |
| Event ID | 93269 |
| Event Description | VariSoft infusion set, Model Number 1002828 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of CA. |
| Quantity | 1679 units |
| Recall Reason | 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. |
| Device Classification | 20231129 |
| Device Code Info | GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376 |
| Center Classification Date | 20231120 |
| Recall Initiation Date | 20231011 |
| Recalling Firm | Unomedical A/S |
| Initial Notification | |
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