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
Gastrointestinal Tubes and Accessories - Product Code KNT
원인
The english only version of the patient care manuals that accompany the device were shipped to a medical facility in italy.
조치
The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.
International Only Distribution -- Country of Italy.
제품 설명
Jejunal Feeding Set, Product Order number FLOWJ-9-20. || This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.