| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01214-1 |
| Product Name/Description |
Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
Product Codes: 110633 & 110634
Multiple lot numbers are affected
ARTG Number: 194549 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Gambro Renal Products is advising the customers of the possibility of a tear in the individual sterile barrier packaging on some of its Polyflux Revaclear/ Polyflux Revaclear Max dialysers. The nature of the defect is such that it is isolated to the package only; the dialyser itself is not damaged. The tears are only on the printed white Tyvek side of the packaging and are readily visible. A tear in the package is a sterility breach; if the product is then used to treat a patient, there is a remote risk of infection. However, that risk is extremely unlikely. Even if the packaging is compromised, the protection caps on the blood ports of the dialyser are protecting the blood fluid path of the device from a potential contamination. Gambro has not received any reports of adverse patient events. |
| Recall Action |
Recall |
| Recall Action Instructions |
Gambro Pty Ltd is requesting the customers to inspect their inventory, discontinue use immediately and quarantine the affected product. Gambro will arrange for the affected stock to be recovered and replacement stock, or a credit note, issued.
This action has been closed out on 23/10/2018 |
| Contact Information |
02 8852 3700 - Gambro Pty Ltd |