| Class 2 Device Recall Elana Catheter Sizer 2.0 | |
Date Initiated by Firm | February 14, 2013 |
Date Posted | April 18, 2013 |
Recall Status1 |
Terminated 3 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 MD 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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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