Z-2261-2025 Class II Ongoing
FDA device recall Z-2261-2025 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: 52 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
- 52 units
Product Description
PARTIAL NEPHRECTOMY 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. NAMC077, NAMC077-02; UDI: 10809160318911, 10809160437971; Kit Lot No. 1591073, 1612261, 1616916, 1632036, 1632038, 1632359.