| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00049-1 |
| Product Name/Description |
System 6 Aseptic Battery Kit
Catalogue: 6126-120-000
Lot Numbers: 1312, 13210, 13209
ARTG Number: 152526 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
The System 6 Aseptic Battery Kit provides a sterile enclosure for the Styker non-sterile battery. The manufacturer has identified the affected lot to have insufficient bond strength at a weld joint associated with the Aseptic Housing, due to an issue during manufacture. Therefore, the quality of the weld may not be as effective as intended. This could lead to the separation of the top section of the housing from the bottom section. This may lead to sterility breaches, loss of surgical control, intra-operative complications and potential delays in surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected units will be replaced via the standard stock replenishment process. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 803 601 - Stryker Australia |