Unomedical A/S Aaholmvej VariSoft infusion set, Model Number 1002827 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VariSoft infusion set, Model Number 1002827
Brand
Unomedical A/S Aaholmvej
Lot Codes / Batch Numbers
GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366, GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366
Products Sold
GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366
Unomedical A/S Aaholmvej is recalling VariSoft infusion set, Model Number 1002827 due to The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026