Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00365-1
Product Name/Description	Cook Bush SL and Bush DL Ureteral Illuminating Catheters (used for trans-illumination of the ureters during laparoscopic or open surgical procedures) Cook Bush SL Ureteral Illuminating Catheter Set Catalogue Numbers: 084100, 084120 , J-BICS-058020 Part Numbers: G16745, G16746, G16737 All Lots Cook Bush DL Ureteral Illuminating Catheter Set Catalogue Numbers: 084520, 084510, J-BICS-078000 Part Numbers: G16747, G16143, G16262 All Lots ARTG Number: 215910
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/03/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	There has been an increase in reports that the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. There have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder and ureter. Potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
Recall Action	Recall
Recall Action Instructions	Customers are advised to quarantine and immediately return any affected product that remains unused to Cook Medical. This action has been closed out on 13/11/2018
Contact Information	1800 777 222 - Cook Medical