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FDA (Device enforcement)Recalled 2025-04-25class ii

Tecfen Medical: 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)

Hazard

Sterility assurance for Ophthalmic knives.

Details from the source

Reason for recall: Sterility assurance for Ophthalmic knives. Distribution: 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. Quantity: 115 unit Lot/code info: Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24081907-02 UDI: 00817618021156

UPC codes

00817618021156

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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