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.
Urologix is recalling certain lots of targis¿ system coolant bag devices distributed over a two week period. the devices are packaged into disposable procedure kits containing a microwave catheter, a coolant bag and a rtu plus¿ balloon.
the reason for this recall involves three lots of coolant bags that contain an increased risk of leakage of water at the sensor module. this leak is detectabl.
조치
Urologix, Inc. sent an "IMPORTANT RECALL INFORMATION" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443.
Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.