Z-3186-2024 Class II Ongoing
FDA device recall Z-3186-2024 was initiated by Unomedical A/S on July 23, 2024 and is designated Class II. Reason for recall: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- July 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
VariSoft Infusion Set, Single Use.
Reason for Recall
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Distribution Pattern
US Nationwide distribution in the state of California.
Code Information
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241