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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 3,362
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
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
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