FDA Device recall Z-0232-2024
VariSoft infusion set, Model Number 1002827
- FDA Device
- Class I
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class I recall of VariSoft infusion set, Model Number 1002827 by Unomedical A S, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0232-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-11 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Unomedical A S |
| Distribution | US |
Product
VariSoft infusion set, Model Number 1002827
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.
Identifiers
| code_info | GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2024%22
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