Tecfen Medical 15 degree Stab Knife sterility assurance recall
Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and 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 medical device recall involving a sterile surgical instrument with a potential failure to maintain sterility. Although no illnesses or injuries are reported in the source text, sterility assurance failures in surgical instruments present a documented risk of harm (infection), meeting the High threshold under the rubric for "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Tecfen Medical is recalling the 15 degree Stab Knife (Model QKN1501), a manual ophthalmic knife intended to be sterile and used for precise incisions during eye surgeries including cataract, vitreoretinal, glaucoma, corneal, and oculoplastic procedures. The recall addresses sterility assurance issues with the product.
The affected product was distributed nationwide in Connecticut and Minnesota, as well as in the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Qatar, Bangladesh, Brazil, and Israel. The recalled lot has Lot Number ZGY23100713-01, with a manufacture date of November 25, 2024, and expiration date of November 24, 2027.
Patients or healthcare providers who have received or used this product should contact Tecfen Medical or their healthcare provider for guidance on appropriate next steps. The product should not be used.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives ar
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-assurance
- infection-risk
Distribution
Distributed nationwide across the United States.
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