| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00362-1 |
| Product Name/Description |
TriForce Peripheral Crossing Set
(intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions)
Catalogue Identified (Prefix/Suffix):
KCXS-5.0- / -RB-0/0-HC
KCXS-5.0- / -RB-0/DAV-HC
KCXS-5.0- / -RB-MPB/0-HC
KCXS-5.0- / -RB-MPB/DAV-HC
Affected Lot Numbers: 6446148, 6446178, 6446172, 6446175, 6446166, 6446157, 6458182, 6446154
ARTG Number: 246412 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are notified to quarantine and immediately return any affected product that remains unused to Cook Medical.
This action has been closed on the 17/09/2018 |
| Contact Information |
1800 777 222 - Cook Medical Customer Service Department |