Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall
Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.
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 sterility concerns for a medical device used in eye surgery. Sterility failures in ophthalmic instruments pose a risk of serious infection and harm; no reported illnesses are stated, making this a high-risk product recall without reported adverse events, consistent with a score of 3.
Plain-English summary
Tecfen Medical is recalling 115 units of its 2.4mm Slit Knife, Angled (Model QKN2461), an ophthalmic knife used to create precise incisions for controlled entry into the eye. The recall is due to sterility assurance concerns.
The affected product was manufactured on November 21, 2024, with an expiration date of November 20, 2027. The lot number is ZGY24081907-02. 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, and Bangladesh, Brazil, and Israel.
Healthcare facilities and individuals who have received this product should discontinue use and contact Tecfen Medical for further instructions regarding the recalled units.
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
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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