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
Cook medical has received six product complaints associated with reports of the 2.6fr curved catheter being mixed with the 4.0fr straight catheter and vice versa. investigation revealed the products were mixed
during processing.
조치
Cook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier.
The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification.
Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
Worldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.
제품 설명
Cook Medical CXI Support Catheter || 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.