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LeMaitre Vascular, Inc. recalls 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre V
Recalled August 24, 2016 · FDA recall Z-2544-2016 · LeMaitre Vascular
Hazard
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable · FDA Class II
Units
380 units
Sold at
Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
Description
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Product
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →