FDAFDA · Food and drugs·Recall number Z-2257-2025
LAVH PACK. Medical convenience kit.
Published August 13, 2025 · Recall initiated: June 11, 2025
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
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- AVID Medical, Inc.
- Distributor
- Domestic: CA, IL, MD, OH, PA, TX, WA.
- Lot
- Model No. USAR053-11; UDI: 10809160372357; Kit Lot No. 1578109, 1585712, 1597106, 1601742, 1601643, 1607925, 1612044, 1621429, 1637117.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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