Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00670-1
Product Name/Description	Cook Beacon Tip angiography catheters Beacon Tip Torcon NB Advantage Catheters Catalogue number: HNBR5.0 Beacon Tip Royal Flush Plus High-Flow Catheters Catalogue number: HNR4.0 Slip-Cath Beacon Tip Catheters Catalogue number: SCBR5.0 Multiple lot numbers ARTG Number: 137861
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/07/2015
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical is initiating a recall of the listed products following reports of catheter tip splits and/or separation. Potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
Recall Action	Recall
Recall Action Instructions	Customers are advised to quarantine any affected product that remains unused and return it to Cook Medical.
Contact Information	1800 777 222 - Cook Medical Customer Service