Tecfen Medical ophthalmic slit knife recall due to sterility assurance
Tecfen Medical is recalling its 3.2mm Slit Knife (model QKN3261), an ophthalmic surgical instrument, due to sterility assurance concerns. The recall affects 26 units distributed worldwide.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard involves sterility assurance of a surgical instrument, which poses a theoretical risk of harm during ophthalmic procedures, fitting the criterion for High (3) severity.
Plain-English summary
Tecfen Medical is recalling the 3.2mm Slit Knife, Angled (model QKN3261), a sterile ophthalmic surgical instrument used to create precise incisions for eye surgery. The recall addresses sterility assurance concerns with the product.
The affected lot (ZGY24022804-05) was manufactured on November 21, 2024, and expires November 20, 2027. A total of 26 units were distributed worldwide, including distribution in the United States (Connecticut and Minnesota) and internationally (Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel).
Affected users should contact Tecfen Medical, the manufacturer, for guidance on the recall and any necessary follow-up actions.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-failure
Distribution
Distributed nationwide across the United States.
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