Z-2253-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
LAP CHOLE PACK. Medical convenience kit.
Reason for Recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Distribution Pattern
Domestic: CA, IL, MD, OH, PA, TX, WA.
Code Information
Model No. VCIH007-06; UDI: 10809160379479, 10809160450758; Kit Lot No. 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, 1643426.