| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00230-1 |
| Product Name/Description |
AMS 800 Artificial Urinary Sphincter Control Pumps
Item numbers (REF): 72400098 and 72404127
Multiple serial numbers
ARTG Numbers: 131706, 165326 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in Australia were released despite not fully meeting the manufacturer's product release criteria. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
AMS is advising that the risk of prophylactic removal of implanted control pumps outweighs any benefit. Physicians are requested to review the information in the Hazard Alert and use normal clinical practice to determine necessary actions. for more details, please see http://www.tga.gov.au/safety/alerts-device-ams800-controlpump-130326.htm . |
| Contact Information |
02 9425 6800 - AMS Australia |