Z-2256-2025 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
- 452 units
Product Description
LAPAROSCOPY 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. VAML025-05, WRNM007-15; UDI: 10809160387696, 10809160432235; Kit Lot No. 1580078, 1580079, 1580407, 1582536, 1585729, 1596605, 1598248, 1598249, 1607780, 1626103, 1629350, 1639643, 1627004.