Recall Z-1143-2013 ยท MCW Catheter, Peripheral, Atherectomy
Elana, Inc.
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.
| Date | Apr 18, 2013 (initiated Feb 14, 2013) |
| Status | Terminated |
| Reason | Distribution of an unapproved device into interstate commerce. |
| Root cause | 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., 1 |
| Quantity | 3 devices |
| Distribution | Distributed in the states of Pennsylvania, Texas, and New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.