Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall
Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.
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 an FDA Class II recall involving a sterile medical device with potential for patient harm if non-sterile instruments are used in ophthalmic surgery, which carries infection risk. No reported illnesses or injuries are stated in the source, but the hazard is real and applicable to medical devices used in sensitive procedures.
Plain-English summary
Tecfen Medical is recalling the 3.2mm Slit Knife, Angled (Model QKN3261), an ophthalmic knife used to create precise incisions for controlled entry into the eye. The recall is being conducted due to sterility assurance issues with the affected units.
The recalled product was manufactured on November 21, 2024, with lot number ZGY24022804-05 and a UDI of 00817618021224. The product was distributed nationwide in Connecticut and Minnesota, as well as internationally to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel. Approximately 26 units are affected by this recall.
Consumers and healthcare facilities who have received this product should discontinue use of the affected lot and contact Tecfen Medical for further instructions. Healthcare professionals should also assess whether any of these devices were used in procedures and take appropriate follow-up action.
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-assurance
- infection-risk
Distribution
Distributed nationwide across the United States.
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