Unomedical A/S: Medical Device Recall in 2023 - (Recall #: Z-0233-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

VariSoft infusion set, Model Number 1002828

Product Classification:

Class I

Date Initiated: October 11, 2023

Date Posted: November 29, 2023

Recall Number: Z-0233-2024

Event ID: 93269

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.

Status: Ongoing

Product Quantity: 1679 units

Code Information:

GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated