[pending] CT DAVINCI. Medical convenience kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-2242-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
The recalled product
- Product
- CT DAVINCI. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. WRNM089
- UDI: 10809160432525
- Kit Lot No. 1627141.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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