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
Insufflator, laparoscopic - Product Code HIF
원인
When operating the device in high flow mode (40l/min, 15 mmhg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red check gas supply symbol would appear on the display, immediately suspending insufflation.
조치
Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers.
Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.
제품 설명
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; || High pressure units (HPU) (40L and 45L). || Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 || The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.