| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00693-1 |
| Product Name/Description |
Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis catheters
Product Codes: ECS1315, ECS1320, ECS1324
Lot Numbers: ALL
ARTG Number: 172150 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medcomp has become aware of the potential for holes developing in the silicone extension tubing of the Hemo-Cath catheters. During insertion, users may clamp over the guidewire which may cause initial damage to the tubing and over time this could develop into a leak.
An initial crack in the tubing on the inside may propagate over time and eventually travel through the full thickness of the tubing developing into a hole that leaks.
These holes may leak when the catheter is being accessed or pressurised during a treatment. The timeframe of when the holes are discovered is immediately post insertion or after several months of usage or longer.
In the event a hole develops in the tubing, there is a potential for blood loss, air emboli, infection, delays in treatment and/or surgical procedure to remove and replace the device prior to continuing a dialysis treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are reminded that during the insertion of the device not to clamp over the guidewire as this may initiate damage to the tubing that could progress into a leak over time. As an ongoing corrective measure, a new stylet tag with this instruction will also be included in future product. No actual product is being recalled from the Market. This action has been closed-out on 12/08/2016. |
| Contact Information |
1300 277 828 - Brandwood Biomedical |