U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Distribution of an unapproved device into interstate commerce.
조치
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.