| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01234-1 |
| Product Name/Description |
Twin-Pass dual access catheters
Model Number: 5200
Multiple lot numbers affected
Supplied through the Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
An investigation of Twin-Pass units has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or inside the distal part of the rapid exchange lumen of Twin-Pass dual access catheters. It is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of an embolism to the patient. There have been no reports of injuries associated with this issue.
This action has been undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall |
| Recall Action Instructions |
Pyramed has advised users to quarantine and return the affected devices.
This action has been closed-out on 11/11/2016. |
| Contact Information |
1800 651 882 - Pyramed |