PlainRecalls
FDA Devices Critical Class I Ongoing

VariSoft infusion set, Model Number 1002828

Reported: November 29, 2023 Initiated: October 11, 2023 #Z-0233-2024

Product Description

VariSoft infusion set, Model Number 1002828

Reason for Recall

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.

Details

Recalling Firm
Unomedical A/S
Units Affected
1679 units
Distribution
US Nationwide distribution in the state of CA.
Location
LEJRE, N/A

Frequently Asked Questions

What product was recalled? ▼
VariSoft infusion set, Model Number 1002828. Recalled by Unomedical A/S. Units affected: 1679 units.
Why was this product 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.hyperglycemia). Diabetic ketoacidosis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Critical. Recall number: Z-0233-2024.

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