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U.S. Department of Health and Human Services

Class 2 Device Recall Elana Catheter Sizer 2.0

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 Class 2 Recall
Elana Catheter Sizer 2.0
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on May 09, 2013
Recall Number Z-1143-2013
Recall Event ID 64538
Product Classification Catheter, Peripheral, Atherectomy - Product Code MCW
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.
Code Information Model 280, S/N 776, S/N 706, S/N 758
Recalling Firm/
Manufacturer
Elana, Inc.
10480 Little Patuxent Pkwy
Suite 400
Columbia, Maryland 21044-3568
For Additional Information Contact Claartje Beks-Ypma
301-215-7010
Manufacturer Reason
for Recall
Distribution of an unapproved device into interstate commerce.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
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: Claartje@elana.com 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.
Quantity in Commerce 3 devices
Distribution Distributed in the states of Pennsylvania, Texas, and New York.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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