| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00251-1 |
| Product Name/Description |
RPK-01 Luer Connector
Lot Number: MCCC310
Expiry Date:13-10-2021
ARTG Number:145174
(Tekmed - Medcomp Long-term Implantable Haemodialysis Catheter Packs - Catheter, haemodialysis, implantable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that there is a difficulty connecting the female Luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site.
To date, there have been no reports of injury in Australia as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit.
New unaffected product is currently being manufactured.
This action has been closed out on 07/11/2018 |
| Contact Information |
02 9487 9999 - TekMed |