Z-0234-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 11, 2023
- Termination Date
- N/A
- 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