[pending] Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 S
Pending LLM rewrite. Source: FDA_DEVICE Z-1951-2025.
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
Sterility assurance for Ophthalmic knives.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
- Manufacturer
- Tecfen Medical
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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