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Volcano Corporation recalls Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move t
Recalled September 24, 2014 · FDA recall Z-2636-2014 · Volcano
Hazard
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. · FDA Class II
Units
8251 total devices (3777 US)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Description
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Product
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Manufacturer(s)
Volcano Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →