Fusion Pushing Catheter 의 안전성 경고

Safety alert

2017-07-11

2017-07-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170711a.html

Medical device safety alert: cook medical fusion pushing catheter medical device manufacturer, cook medical, has issued a medical device safety alert concerning its fusion pushing catheter. the recorder number of the affected product is fs-pc-7. the manufacturer is initiating a voluntary recall of the cook fusion pushing catheter. the graphic on the product label on the fs-pc-7 device shows the outer diameter (od) of the pushing catheter is 7fr. however, the od of the pushing catheter for the fs-pc-7 device is 6fr; therefore the od has been incorrectly represented on the label. this issue impacts the product label only. according to the manufacturer, the device has been shown in design verification and validation during simulated use testing that it can be effectively used with a 7fr stent (as indicated on the label that it can be used with a 7fr stent). in summary there is negligible/low risk associated with using the current device, and there are no immediate or long range health consequences as a result of this labeling error. the manufacturer advises users to examine inventory to determine if they have the affected products. if you are in possession of the affected products, please contact your supplier for necessary actions. according to the manufacturer, the affected products are distributed in hong kong. posted on 11 july 2017.