Varisoft recallZ-0233-2024 · Unomedical A/S · initiated Oct 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Unomedical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.hyperglycemia). Diabetic ketoacidosis.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0233-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 11, 2023
- Posted by the FDA
- Nov 21, 2023
- Recalling firm
- Unomedical A/S
- Quantity
- 1679 units
- Product code
- FPA
- FDA submissions
- K162812
- Distribution
- US Nationwide distribution in the state of CA.
Product description
VariSoft infusion set, Model Number 1002828
Code information (models, lots, serial numbers)
GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Varisoft™ 1002828Unomedical A/S · Set, Administration, Intravascular2 recalls172 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93269).
- Z-0232-2024 · Open, ClassifiedVariSoft infusion set, Model Number 1002827
- Z-0234-2024 · Open, ClassifiedVariSoft infusion set, Model Number 1002830
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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