Z-1953-2025 Class II Ongoing
FDA device recall Z-1953-2025 was initiated by Tecfen Medical on April 25, 2025 and is designated Class II. Reason for recall: Sterility assurance for Ophthalmic knives. The recall status is ongoing. Affected quantity: 38 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- April 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
Product Description
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 knives are used to create precision incisions in vitrectomy procedures. Component: No
Reason for Recall
Sterility assurance for Ophthalmic knives.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.
Code Information
Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY23062808-02 UDI: 00817618021422