| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00087-1 |
| Product Name/Description |
Peristeen Anal Irrigation System
All lot numbers affected
ARTG Number: 135449 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Following the publication of a review article on the best practice of transanal irrigation in adults, and post-market surveillance Coloplast has decided to update the instructions for use. The update includes changes to the sections indication, contraindications, precautions, warnings and introduces instruction for more thorough patient examination before starting anal irrigation treatment. The potential risks that may result from the use of the device have not changed and there are no changes or modifications to the Peristeen Anal Irrigation System. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Coloplast is writing to all hospitals and patients to inform them of the updates to the instructions for use.
Further information on this issue has been provided on the TGA website at - http://www.tga.gov.au/safety/alerts-device-peristeen-anal-irrigation-system-140219.htm#.UwWXnbTTQgs |
| Contact Information |
1800 653 317 - Coloplast Pty Ltd |