| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00206-1 |
| Product Name/Description |
FX CorDiax High-Flux dialysers and FX CorDiax Haemodiafilters
Reference Numbers: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00005653, F00005654, F00001593, F00001594, F00001595, F00005655, F00005656, F00005657
ARTG Numbers: 120311 & 214797 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Fresenius have observed an increased number of cases of hypersensitivity and hypersensitivity-like reactions including life threatening events during haemodialysis and haemodiafiltration treatments involving FX CorDiax dialysers. A product specific cause or mechanism is not known yet.
These reactions occurred mainly both in the first treatment hour and within the first weeks of treatment with the FX CorDiax dialysers. The symptomatology varies and includes: dyspnoea, chest congestion, bronchospasm, respiratory arrest, hypotension, tachycardia, urticaria, erythema, flushing, angioedema, ocular hyperaemia, pruritus, abdominal pain, nausea, convulsions and unconsciousness. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ustomers are advised to carefully monitor patients who have not previously been treated with FX CorDiax dialyser, or who have shown possible hypersensitivity symptoms during previous treatments, or who have a history of allergy including asthma. Patients with known hypersensitivity to any of the dialyser’s material must not be treated with these dialysers.
In patients not treated with these dialysers before and incident patients starting HD or HDF therapy, the treatment intensity shall be gradually increased to permit adequate adaptation. If severe hypersensitivity or hypersensitivity like reactions occur, the dialysis must be discontinued and the blood from the extracorporeal system must not be returned to the patient. Initiate appropriate emergency medical treatment. The Instructions For Use (IFU) document has been updated with suitable additional warnings to alert users to this potential issue. This action has been closed-out on 30/08/2016. |
| Contact Information |
02 9466 8048 - Frensenius Medical Care |