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
Catheter, urological - Product Code KOD
원인
Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
조치
Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template.
For questions, contact your local sales representative or call Customer service at 1-866-246-6990
Worldwide Distribution and (USA) Nationwide Distribution.
제품 설명
RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.