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
Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
원인
The wire control port of these devices may be missing due to omission of a manufacturing activity.
조치
The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed.
Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at cws.complaints@cookmedical.com or 1-336-744-0157.