VariSoft infusion set, Model Number 1002828 Recall
Issued November 29, 2023 · Unomedical A/S
In November 2023, Unomedical A/S recalled the VariSoft infusion set, Model Number 1002828, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using VariSoft infusion set, Model Number 1002828 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Unomedical A/S to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Unomedical A/S
- Category
- Health
- Recall date
- November 29, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of CA.
- Recall number
- FDA-Z-0233-2024
- Made in
- Denmark
- Issuing agency
- FDA
In context
- Unomedical A/S has 2 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.