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
Stent, ureteral - Product Code FAD
원인
Labeling: statement was added to the warnings/precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
조치
Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action required:
Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use.
If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter.
This notification should be carried out to the user level.
This product notification is being made with the knowledge of the Food and Drug administration.
We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.
For further questions, please call (770) 784-6220.