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
Shunt, central nervous system and components - Product Code JXG
원인
Aesculap inc. (aic (usa)) initiated a recall of miethke shunt system, dual switch valve, due to incorrect product labeling on three units. the incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. however, the expiration date on the outer box was correct. no patient injuries were reported as a result of this issue.
조치
An important correction & removal notification letter, dated October 24, 2014, was sent to the sole consignee who received the affected device. The letter identified the product, problem, and action to be taken.