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
Microwave Delivery System - Product Code MEQ
원인
The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
조치
A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
Individual Catheter lot numbers: M002671,M002672, M002589 and M002736 for model TA1121D. Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205, KP0011206.