Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall
Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving a surgical instrument with a sterility concern. Class II recalls can pose serious risk of adverse health consequences, and sterility failures in ophthalmic surgical instruments present significant infection risk to patients undergoing procedures.
Plain-English summary
Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight, Model QKN2312, an ophthalmic surgical knife used to create precision incisions during vitrectomy procedures. The recall was initiated due to sterility assurance for the affected product.
The recalled lot (ZGY23062808-02) was manufactured on November 21, 2024, with an expiration date of November 20, 2027. A total of 38 units were distributed to healthcare providers in Connecticut and Minnesota in the United States, as well as internationally to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
Patients or healthcare providers who have this product should contact Tecfen Medical for further guidance regarding the recall. The affected units are identified by UDI 00817618021422 and lot number ZGY23062808-02.
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
- sterility-assurance
- infection-risk
Distribution
Distributed nationwide across the United States.
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