| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00971-1 |
| Product Name/Description |
Argyle Single Lumen Polyurethane Umbilical Vessel Catheter
(Intended for short-term vascular access via umbilical vessels in neonatal patients)
Product IDs: 8888160325, 8888160333, 8888160341
ARTG Number: 149128 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
The instructions for use was updated to address the increasing use of disinfectants containing alcohol and/or acetone to clean vascular access devices. The use of these disinfectants can cause damage to the polyurethane contained in the catheter and make it more susceptible to physical damage, which may ultimately lead to the need to replace the catheter. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien has updated the instructions for use for polyurethane single lumen umbilical vessel catheters to include additional information on the care of the device. |
| Contact Information |
02 9429 3100 - Covidien Product Manager |