“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.
The heat exchanger for cardioplegia is used for the regulation of the temperature of cardioplegic-osseous solutions and crystalloid cardioplegic solutions during extracorporeal circulation.
It is a portable refrigeration and heating device with 2 or 3 circuits (independent of the water connections) indicated for use with a heart-lung machine or for controlling the temperature of the water circuits during an extracorporeal perfusion. includes water circuits to control the temperature of the blood (in the oxygenator), in thermal or hypothermic blankets or in the cardioplegia solutions
It is a portable refrigeration and heating device with 2 or 3 circuits (independent of the water connections) indicated for use with a heart-lung machine or for controlling the temperature of the water circuits during an extracorporeal perfusion. Includes water circuits to control the temperature of the blood (in the oxygenator), in thermal or hypothermic blankets or in the cardioplegia solutions.