FDAFDA · Food and drugs·Recall number Z-3186-2024
VariSoft Infusion Set, Single Use.
Published September 25, 2024 · Recall initiated: July 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Unomedical A/S
- Distributor
- US Nationwide distribution in the state of California.
- Lot
- UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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