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FDA (Device enforcement)Recalled 2023-07-13class ii

LeMaitre Vascular, Inc.: The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulo

Hazard

Burrs (molding flash) on the cutter may tear the harvested vien

Details from the source

Reason for recall: Burrs (molding flash) on the cutter may tear the harvested vien Distribution: International distribution to the countries of Belgium, France, Germany, and United Kingdom. Quantity: 225 units Lot/code info: (1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840663110483 Lot Numbers: All lots starting with CHV. Only lots beginning with CHV are being recalled. Older lots (with CL lot prefixes) are not being recalled. REF (Catalog #) LOT Catalog Number: (1)40025 Lot Number: CHV1003, CHV1006, CHV1022 (2) 40030 Lot Number: CHV1002, CHV1004, (3) 40035 Lot Number: CHV1001, CHV1005

UPC codes

00840663110469, 00840663110476, 00840663110483

Source

Official record: FDA (Device enforcement)

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

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