| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00483-1 |
| Product Name/Description |
Catheters with Beacon Tip Technology
Multiple products/catalogue numbers affected
All lots affected
ARTG Numbers: 137861, 154909, 153374, 153375,154911, 137861, 214869, 137911, 212573,133996, 208185, 207779 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. The preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of Vaporised Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. It is recognised that there may be other undetermined contributors to this issue and continue to investigate.
Potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolisation to the heart or lungs, or occluding blood flow to end organs. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cook Medical is advising users to quarantine and return any unused product.
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 777 222 - Cook Medical - Customer Relations Department |