Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set 의 안전성 경고

Safety alert

2017-03-08

2017-03-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170308.html

Medical device safety alert: cook medical cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set as below: cook bush sl ureteral illuminating catheter set catalog identifier (part number): 084100 (g16745), 084120 (g16746) and j-bics-058020 (g16737) cook bush dl ureteral illuminating catheter set catalog identifier (part number): 084520 (g16747), 084510 (g16143) and j-bics-078000 (g16262) the manufacturer is initiating a voluntary recall of all lot numbers of the affected products. they have received an increased number of reports where 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. according to the manufacturer, potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin. the manufacturer advises users to examine inventory immediately to determine if they have the affected products. the affected products should be quarantined and returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 march 2017.