Z-3186-2024 Class II Ongoing
FDA device recall Z-3186-2024 was initiated by Unomedical A/S on Jul 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
- Sep 25, 2024
- Initiation Date
- Jul 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3186-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026