| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00052-1 |
| Product Name/Description |
AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.
AFFINITY NT Cardiotomy Venous Reservoir stand-alone uncoated
Code 540, Model 61399409462
All Unexpired
AFFINITY NT Cardiotomy Venous Reservoir stand-alone Trillium coated,
Code 540T, Model 95249
All Unexpired
ARTG: Number: 132278 (Medtronic Australasia Pty Ltd - Reservoir, blood, cardiopulmonary bypass) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
During internal testing, Medtronic identified the potential for a sterile barrier breach in the pouch of all lot numbers of the above listed products. Other packaging configurations, such as integrated Affinity NT Hollow Fiber Oxygenator/Cardiotomy Venous Reservoirs and Perfusion Tubing Packs with Affinity NT Cardiotomy Venous Reservoirs are not affected by this issue. No other Medtronic products are affected by this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to quarantine all unused, non-expired, affected product for return to Medtronic.
This action has been closed out on 24/09/2018 |
| Contact Information |
02 9857 9000 - Medtronic Australasia |