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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description 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.
Recall Number Z-1143-2013
Classification Class II
Code Info Model 280, S/N 776, S/N 706, S/N 758
Product Distributed Qty 3 devices
Reason For Recall Distribution of an unapproved device into interstate commerce.

Event Detail

Event Id 64538
Product Type Devices
Status Ongoing
Recalling Firm Elana, Inc.
City Columbia
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of Pennsylvania, Texas, and New York.