FDA-Device2014-09-24Class II
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.
Volcano Corporation
Hazard
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Affected count
8251 total devices (3777 US)
Manufactured in
2870 Kilgore Rd, N/A, Rancho Cordova, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2636-2014Don't want to check this manually?
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