Device product
VariSoft Infusion Set, Single Use.
Z-3186-2024
Product summary
- Firm
- Unomedical A/S
- Event
- Event 95224
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3186-2024
Official wording
Reason: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Code information: UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Distribution pattern: US Nationwide distribution in the state of California.
Derived failure modes
-
Unknown
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".