| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00615-1 |
| Product Name/Description |
Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
Model number: BS1003FW
Lot number: 13D1394D3EB780
Expiry date: 2016-04
ARTG number: 130531 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that there is a potential problem with the loosening of the Y connector on the hub of the delivery sheath which is outside the patient's body during delivery of the stent.The outer sheath and Y connector should be adjoined each other using glue as well as screw compression, however the gluing process was skipped in some cases with the affected lot number during manufacturing. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pyramed is asking customers to return the affected stock for replacement with unaffected stock. |
| Contact Information |
1800 651 882 - Pyramed |