Food, drugs, devices › Unomedical A/S
Device recall: VariSoft infusion set, Model Number 1002827
Unomedical A/S (LEJRE, N/A) initiated this device recall on 11 Oct 2023; FDA lists 3 product records under event 93269, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Unomedical A/S has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Unomedical A/S, LEJRE, N/A, Denmark.
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.…"
Distribution
"US Nationwide distribution in the state of CA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0232-2024 | VariSoft infusion set, Model Number 1002827 | 8028 units | Class I | Ongoing | 29 Nov 2023 |
| Z-0233-2024 | VariSoft infusion set, Model Number 1002828 | 1679 units | Class I | Ongoing | 29 Nov 2023 |
| Z-0234-2024 | VariSoft infusion set, Model Number 1002830 | 3362 units | Class I | Ongoing | 29 Nov 2023 |
Context
Other enforcement events for Unomedical A/S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Jul 2024 | VariSoft Infusion Set, Single Use. | Device | Class II | 1 |
| 5 Mar 2024 | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Device | Class II | 1 |
| 21 Jul 2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion | Device | Class II | 1 |
All 4 events for Unomedical A/S
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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.…"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of CA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.