VariSoft infusion set recall
VariSoft infusion set, Model Number 1002827
Why was VariSoft infusion set recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366
- Product
- VariSoft infusion set, Model Number 1002827
- Recalling firm
- Unomedical A/S
- Quantity
- 8028 units
- Distribution
- US Nationwide distribution in the state of CA.
- Recall date
- November 29, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)