Z-0234-2024 Class I Ongoing
FDA device recall Z-0234-2024 was initiated by Unomedical A/S on Oct 11, 2023 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 3362 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 29, 2023
- Initiation Date
- Oct 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3362 units
Product description
VariSoft infusion set, Model Number 1002830
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.
Distribution pattern
US Nationwide distribution in the state of CA.
Code information
GTIN 05705244018792, Serial Numbers: 5388368; GTIN 05705244018785, Serial Numbers: 5388368
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0234-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026