| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01156-1 |
| Product Name/Description |
Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms)
NV Excelsior SL-10 90deg 2-Tip Neurovascular Microcatheter
Catalogue No: 168191
Lot No: 17045959
ARTG Number: 177031
NV Neuroform 3EZ-3.0x15mm, 3EZ-3.5x15mm Stent System
Catalogue Nos: EN3E3015, EN3E3515
Lot Nos: 17032024, 17032027
ARTG Number: 172281 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware that certain lots of the affected Neurovascular products have incorrect product expiry dates printed on the packaging. All products are currently still within their validated expiry date, the earliest expiry date being April 2015. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting users inspect stock and return affected stock to Stryker for replacement. |
| Contact Information |
1800 803 601 - Stryker RAQA Coordinator |