Ophthalmic surgical knives recalled due to sterility assurance concerns
Tecfen Medical is recalling 38 units of MVR Sideport Knives (Model QKN2312) due to sterility assurance concerns. The surgical instruments used in eye procedures may pose an infection risk if sterility cannot be assured.
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 FDA Class II recall involves sterile surgical instruments used in high-risk eye procedures where sterility is critical to patient safety. Although no illnesses have been reported, the inability to assure sterility poses a significant risk of serious infection, fitting the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Tecfen Medical is recalling 38 units of 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312, Lot Number ZGY23062808-02) manufactured on November 21, 2024. These sterile ophthalmic knives are designed for use in vitrectomy procedures.
The recall was initiated due to sterility assurance concerns. Sterile surgical instruments are essential for patient safety in eye surgery, as instruments that may not meet sterility requirements could introduce infection during procedures.
The affected units were distributed worldwide, including throughout the United States (Connecticut and Minnesota) and to international locations including the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
Healthcare facilities currently in possession of the recalled knives should immediately discontinue use and contact Tecfen Medical for device return and replacement instructions.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
- Manufacturer
- Tecfen Medical
- Hazard
- contamination
- infection-risk
- sterility-failure
Distribution
Distributed nationwide across the United States.
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