VariSoft Infusion Set recalled for defective connector prone to unintended disconnection
Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.
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 is a Class I FDA recall, which mandates a minimum severity score of 4. Although no illnesses or injuries are explicitly reported in the source text, the manufacturing defect poses serious risk of missed insulin delivery leading to life-threatening complications including diabetic ketoacidosis.
Plain-English summary
The VariSoft infusion set, Model Number 1002827, used with tandem insulin pumps, is being recalled by Unomedical A/S due to a manufacturing defect. The connector piece may be damaged during manufacturing, making it prone to disconnection with less force than intended.
If the connector becomes detached without being noticed—particularly during sleep—the infusion set will not deliver basal insulin doses. This missed medication can result in elevated blood glucose and ketone levels (nocturnal hyperglycemia) and potentially lead to diabetic ketoacidosis, a serious medical condition.
The recall involves 8,028 units of the VariSoft infusion set. If you use this product, consult your healthcare provider about the recall and whether your infusion set is affected.
The recalled product
- Product
- VariSoft infusion set, Model Number 1002827
- Manufacturer
- Unomedical A/S
- Hazard
- connector-damage
- disconnection
- missed-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 (6)
- GTIN 05705244018709
- Serial Numbers: 5388357
- 5388362
- 5388372
- 5388366
- GTIN 05705244018693
Distribution
Distributed nationwide across the United States.
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