CLASS I ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
VariSoft infusion set recalled by Unomedical A/S
Unomedical A/S is recalling VariSoft infusion set, distributed nationwide in the US. The recall was initiated on 11 Oct 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0232-2024
- FDA event ID
- 93269
- Recalling firm
- Unomedical A/S, LEJRE, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Oct 2023
- FDA classified
- 20 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 11 Oct 2023 | Recall initiated by company | |
| 20 Nov 2023 | Classified by FDA | +40 days |
| 29 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VariSoft infusion set, Model Number 1002827
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Is VariSoft infusion set recalled?
Yes. Unomedical A/S recalled VariSoft infusion set on 11 Oct 2023. The recall is Class I and its status is Ongoing. Recall number Z-0232-2024.
Why was it recalled?
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.
Which lots are affected?
GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366
Where was it sold?
US Nationwide distribution in the state of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Unomedical A/S
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | VariSoft Infusion Set, Single Use recalled by Unomedical A/S | Unomedical A/S | Packaging Defects | Nationwide |
| Device | CLASS II | Neria Soft Infusion Set, Product recalled by Unomedical A/S | Unomedical A/S | Other | Nationwide |
| Device | CLASS I | VariSoft infusion set recalled by Unomedical A/S | Unomedical A/S | Device Malfunction | Nationwide |
| Device | CLASS I | VariSoft infusion set recalled by Unomedical A/S | Unomedical A/S | Device Malfunction | Nationwide |
| Device | CLASS II | Autosoft 90, model numbers 1000282 recalled by Unomedical A/S | Unomedical A/S | Other | CA |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |