Recall of TriForce Peripheral Crossing Set(intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions)

Recall

RC-2017-RN-00362-1

Class I

2017-03-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00362-1

There has been an increase in reports of blood loss associated with devices using a specific haemostatic valve design (referred to as the “blue” valve or polyisoprene valve). in november 2015, products manufactured with the haemostatic blue valve design were either made obsolete or changed to incorporate a different valve design with improved haemostasis. cook has continued to receive reports of blood loss associated with the earlier generation products containing the “blue” valve and therefore has initiated this action on those devices. potential adverse events that may occur if these devices are used in the arterial system include delay in procedure and blood loss. if devices are used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism.

Customers are notified to quarantine and immediately return any affected product that remains unused to Cook Medical.