Recall Z-2148-2015 ยท KRA Catheter, Continuous Flush
EKOS Corporation
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Cont
| Date | Jul 20, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. |
| Root cause | Vendor change control |
| Action | Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer |
| Quantity | 46 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |