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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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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
Distribution Pattern Distributed in the states of Pennsylvania, Texas, and New York.

Product Detail

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