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.
데이터 추가 비고
Catheter, continuous flush - Product Code KRA
원인
The ekosonic kit, including the individually labeled microsonic device (msd) and intelligent drug delivery catheter (iddc) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the msd actual working length is 106 cm.
조치
All affected consignees were contacted by telephone January 20- 22, 2016.
The URGENT VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call:
Jocelyn Kersten
Vice President, Regulatory and Clinical Affairs
EKOS Corporation, a BTG International Group Company
425-415-3132
Jocelyn.kersten@ekoscorp.com
Distributed in the states of AZ, CA, MA, MI, OH, and VA.
제품 설명
EkoSonic Endovascular System, Catalog Number 500-56112. || It 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 Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface || Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.