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
Balloon Inflation Syringe - Product Code MAV
원인
Product sterility may be compromised due to breach of package seal integrity.
조치
Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.
Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
제품 설명
Medtronic¿ Everest¿ 30 Disposable Inflation Device, AC3200. || Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.