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
Device, hemostasis, vascular - Product Code MGB
원인
Abbott vascular is recalling the starclose se vascular closure system because it may exhibit difficulty or failure to deploy the starclose se clip.
조치
An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questions are instructed to contact their local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.