| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00052-1 |
| Product Name/Description |
Central Venous Catheter and Pressure Monitoring Sets
Single Lumen Central Venous Catheter Sets & Trays
Femoral Artery Pressure Monitoring Catheter Sets & Trays
Radial Artery Pressure Monitoring Catheter Sets & Trays
Reference Part Numbers (RPN): C-NPMS-501J-15, C-PMS-301-FA, C-PMS-301J-FA, C-PMS-301J-PED, C-PMS-301-RA, C-PMS-400-RA, C-PMS-401-FA and C-PMS-401J-FA
Multiple Lot Numbers
ARTG Numbers: 154878 and 156190 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Certain Central Venous Catheters and Pressure Monitoring Sets are being recalled due to an issue being identified with a manufacturing process that could result in the potential for catheter tip fracture and/or separation.
Potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. There have been no reports of illness or injury associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 777 222 - Cook Medical |