| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00711-1 |
| Product Name/Description |
HOYA Corporation (PENTAX Medical) – Gas/Water Feeding Valve
Product Codes: PTX-OF-B130 & PTX-OF-B194
ARTG Number: 204881 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
This action is taken to inform users of a change in the Instructions for Use related to the proper use of the lubricant oil (PTX-OF-Z11) applied on the PTX-OF-B130 and PTX-OF-B194 Gas/Water Feeding valves, as supplied by PENTAX Medical.The Pentax Brand Silicon Oil PTX-OF-Z11 must always be used for the O-rings of Pentax Gas/Water Feeding valves. At this time, Pentax Medical can only recommend PTX-OF-Z11 as it is the only lubricant validated by Pentax Medical for use with these valves. If other oil were applied to the O-Ring of PTX-OF-B194 this may impact the functionality, and it may cause uncontrolled, continuous gas flow or excessive gas insufflations, resulting in a patient injury such as pneumatic perforation or gas (air) embolism. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing updated Instructions for Use with the customer letter. Users are also advised that If the valve does not function properly (does not move smoothly, feels sticky, leaks air or water) remove it and inspect for worn or damaged O-Rings. Replace O-rings as necessary. In case the valve does not function properly during an examination, stop CO2 or water supply at the primary valve (i.e CO2 insufflator or CO2 bombe) immediately. |
| Contact Information |
1800 429 551 - Device Technologies |