| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01241-1 |
| Product Name/Description |
TWISTER PLUS Rotatable Retrieval Device 22mm and 26mm (used in flexible endoscopes as a retrieval device for foreign bodies, such as polyps and food boluses)
Catalogue Numbers: 6141 and 6142
Material Number: M00561410, M00561411, M00561412, M00561420, M00561421, M00561422
Multiple Lot numbers affected
Expiration date: 31 July 2015 to 30 September 2015
ARTG Number: 166708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of Boston Scientific that the packages of TWISTER PLUS may not be fully sealed, affecting the sterility of the device. Use of a retrieval device from a package with an open seal may impart a patient risk of infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising users to segregate the affected product and return to Boston Scientific for credit. |
| Contact Information |
02 8063 8340 - Boston Scientific Quality Assurance |