Fusion Pushing Catheter 의 리콜

Recall

RC-2017-RN-00852-1

Class III

2017-07-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00852-1

Cook medical has identified a labelling issue with the 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.The device has always been manufactured to the correct specification (6fr) and 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).To date, there have been no complaints or reports of injury/illness due to this issue.

Cook Medical is requesting customers: 1. Examine inventory immediately to identify and quarantine affected products; 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days; 3. Return any affected products as per the instructions in the acknowledgement and receipt Form; 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (07 3841 3905) or email to cau.custserv@cookmedical.com 5. Report adverse events to Cook Medical Customer Relations at cau.custserv@cookmedical.com , or call toll free -1800 777 222 Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: cau.custserv@cookmedical.com.