VariSoft Infusion Set Model 1002828 Recalled for Connector Detachment Risk
The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I recall involves a defect causing unintended disconnection of an insulin infusion set, potentially leading to missed insulin doses and diabetic ketoacidosis. FDA Class I recalls score 4 or higher per recall classification standards.
Plain-English summary
The FDA is recalling 1,679 units of the VariSoft infusion set (Model Number 1002828) manufactured by Unomedical A/S. The product is used with Tandem insulin pumps to deliver insulin to patients with diabetes.
A manufacturing defect causes damage to the connector piece of the infusion set. This damage makes the connector more likely to disconnect unintentionally, requiring less force to separate than the design intended.
If a patient does not notice the disconnection, the insulin pump will not deliver basal insulin doses. This missed dosing can result in elevated blood glucose and ketone levels, particularly during sleep, potentially leading to diabetic ketoacidosis—a serious and potentially life-threatening condition.
Patients or healthcare providers who have this product should stop using it and consult their healthcare provider about replacement options.
The recalled product
- Product
- VariSoft infusion set, Model Number 1002828
- Manufacturer
- Unomedical A/S
- Affected units
- 1,679
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- GTIN 05705244018730
- Serial Numbers: 5388367
- 5388376
- GTIN 05705244018723
- Serial Numbers: 5388367. 5388376
Distribution
Part of a larger recall action
This product is one of 3 recalled by Unomedical A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Unomedical A/S
See all →- ModerateVariSoft Infusion Sets recalled due to incorrect secondary packaging
FDA (Devices) · 2024-09-25
- HighNeria Soft Infusion Sets recalled due to incorrect instruction manual
FDA (Devices) · 2024-04-24
- CriticalVariSoft Insulin Infusion Set Recalled Over Premature Connector Disconnection
FDA (Devices) · 2023-11-29
- SevereVariSoft Infusion Set recalled for defective connector prone to unintended disconnection
FDA (Devices) · 2023-11-29
- HighInsulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions
FDA (Devices) · 2022-10-05
Same hazard · connector detachment
See all →- HighMedline cardiovascular draping and basin kits contain substandard catheters
FDA (Devices) · 2026-06-24
- HighMedline 14 Fr coude latex catheters fail performance specifications
FDA (Devices) · 2026-06-24
- HighMedline red rubber urethral catheters fail applicable performance specifications
FDA (Devices) · 2026-06-24
- HighMedline vasectomy reversal kits contain catheters failing performance specifications
FDA (Devices) · 2026-06-24
- HighMedline pre-connected urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24