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Terminated

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.

FDA Recall Z-1143-2013 · Posted 2013-04-18

Recalling FirmElana, Inc.
Recall StatusTerminated
Product CodeMCW
Date Initiated2013-02-14
Date Terminated2013-05-09
Product Quantity3 devices

Reason for Recall

Distribution of an unapproved device into interstate commerce.

Firm Action

Elana Inc. issued an Urgent: Medical Device Recall letter on February 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the Elana Catheter Sizer 2.0 as soon as possible. The Sizer 2.0 was intended as an optional accessory to the Elana Surgical Kit. The Elana Surgical Kit may be used properly without the Elana Catheter Sizer 2.0. Please acknowledge receipt of these instructions immediately by Email: [email protected] or Fax: 301-215-7038. The return shipping address for the Sizer 2.0 is Elana, Inc., 10480 Little Patuxent Parkway, Suite 400, Columbia, MD 21044 USA. Contact information for questions: Phone: 301-215-7010 or 443-538-4923 or +1 31 30 2537276 www.elana.com.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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