| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00909-1 |
| Product Name/Description |
Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and i10/K10 series )
All lot numbers affected
ARTG Number: 204881 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has been informed about a product issue involving the OF-B194 Gas/Water Feeding Valve. The reported defect may prevent stoppage of the supply of CO2 gas during an endoscopic procedure with the potential for serious hazard to the patient, including bowel perforation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is advising customers to stop use of the PTX-OF-B194 Gas/Water Feeding Valve. Device Technologies will arrange for the affected stock to be collected. New stock of PTX-OF-B194 will be available by the end of September 2013. In the interim, customers are asked to use the alternative OF-B188 valve provided. |
| Contact Information |
1800 429 551 - Device Technologies Australia |