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Elana, Inc. recalls Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of
Recalled April 24, 2013 · FDA recall Z-1143-2013 · Elana
Hazard
Distribution of an unapproved device into interstate commerce. · FDA Class II
Units
3 devices
Sold at
Distributed in the states of Pennsylvania, Texas, and New York.
Description
Distribution of an unapproved device into interstate commerce.
Product
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Manufacturer(s)
Elana, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →