Z-2258-2025 Class II Ongoing
FDA device recall Z-2258-2025 was initiated by AVID Medical, Inc. on June 11, 2025 and is designated Class II. Reason for recall: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. The recall status is ongoing. Affected quantity: 128 units.
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
- 128 units
Product Description
MAJOR THORACOSCOPY BASIN. 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. NIHB0022-09, NIHB0022-11, NIHB0022-12; UDI: 10809160381311, 10809160403730, 10809160440940; Kit Lot No. 1580032, 1590461, 1590463, 1604743, 1613180, 1613182, 1618989, 1641040.