FDA Device Recall Z-0233-2024
Unomedical A/S · LEJRE, N/A
Class I — life-threatening Ongoing
Device
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.
Recall record
- Recall number
Z-0233-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- US Nationwide distribution in the state of CA.
- Recall initiated
- 2023-10-11
- Classified by FDA Center
- 2023-11-20
- FDA published
- 2023-11-29
- Recalling firm
- Unomedical A/S
- Firm location
- LEJRE, N/A, Denmark
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.