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
Continous Flush Catheter - Product Code KRA
원인
Catheter disconnection. there is a potential for the catheter to disconnect from the catheter interface cable (cic) pod which connects to the control unit.
조치
Firm representatives will visit and distribute connector clips and instructions for use to consignees beginning 04/01/2008 at no cost to the consignee.
Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.