| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01573-1 |
| Product Name/Description |
LQT6283LB In-line leucoreduction system for red cell concentrates with LCRD2 Leucoflex soft filter
ARTG Number: 142856 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
MacoPharma was informed of a number of fast filtrations for reference NPT6280LA that includes the LCRD2 filter. This has led to some instances of ineffective filtration through the media of the LCRD2 filter. The frequency has increased to an average of 100 DPM (defect per million) (0.01%) on production from the month of June 2016. This sporadic defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress.
This defect is easily detectable during the initial stages of filtration by the presence of blood moving into the downstream chamber (exit side of filter) and tubing at the central point of the filter during priming. This leads to a very quick filtration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Macopharma is advising customers that they should pay particular attention to the priming of the filter. Unaffected filters may continue to be used. All priming faults (direct passage) must be discarded and should be returned to Macopharma Australia for analysis. Macopharma will supply a credit note for the loss of affected product. This action has been closed out on 16 June 2017. |
| Contact Information |
02 9904 7303 - Macopharma Australia |