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
Introducer, Catheter - Product Code DYB
원인
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
조치
The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
제품 설명
AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602