VariSoft Insulin Infusion Set Recalled Over Premature Connector Disconnection
Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification. The documented manufacturing defect in the connector can cause missed insulin dosing, which can result in diabetic ketoacidosis, a serious and potentially life-threatening condition.
Plain-English summary
The VariSoft infusion set (Model 1002830) is used in conjunction with Tandem insulin pumps to deliver basal insulin doses. Approximately 3,362 units have been distributed.
A manufacturing defect damages the connector piece on these infusion sets. The damage causes the connector to detach more easily than intended, requiring less force to disconnect than the design specifies.
When the set disconnects without detection—particularly during sleep—basal insulin delivery is interrupted. This missed dosing can result in elevated blood glucose and ketone levels (nocturnal hyperglycemia), which can progress to diabetic ketoacidosis.
The recalled product
- Product
- VariSoft infusion set, Model Number 1002830
- Manufacturer
- Unomedical A/S
- Hazard
- connector-failure
- missed-insulin-dosing
- diabetic-ketoacidosis
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 (3)
- GTIN 05705244018792
- Serial Numbers: 5388368
- GTIN 05705244018785
Distribution
Distributed nationwide across the United States.
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