Reported Nov 29, 2023 · Ongoing
VariSoft infusion set, Model Number 1002828
Unomedical A/S
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unomedical A/S · Aaholmvej 1 - 3 · LEJRE, N/A · N/A
Is this the product you have?
- VariSoft infusion set, Model Number 1002828
- Lot codes and dates
- GTIN 05705244018730
- Serial Numbers
53883675388376GTIN 05705244018723
- Serial Numbers5388367. 5388376
- Amount recalled
- 1679 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- CA
Why it was recalled
Stop using this product now
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.hyperglycemia). Diabetic ketoacidosis.
Using this product could cause serious injury, illness or death — stop using it now.
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