| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00477-1 |
| Product Name/Description |
Autotome RX (20mm CUT WIRE) Cannulating Sphincterotome
Material number: M00545170
UDI: 08714729444749
Lot number: 33280747
Expiry date: 23 January, 2027
ARTG 126642
(Boston Scientific Pty Ltd - Endotherapy device, active, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific is initiating a removal of one lot of Autotome RX Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should Immediately discontinue use of and segregate affected product for return to Boston Scientific
Note: a Credit will be issued for all affected product that is properly returned to Boston Scientific. |
| Contact Information |
02 8063 8340 - BSC Quality Representative |