| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00392-1 |
| Product Name/Description |
PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)
Catalogue Numbers: 0620040610, 0620040611, 0620040600
Multiple Lot Numbers affected
ARTG Number: 139712 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified that when the affected device is operating with a flow setting of 18L/min or greater and connected to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red “Check Gas Supply” symbol would appear on the display, immediately suspending insufflation.
The failure produced by the defective product is the red “Check Gas Supply” error on the display that occurs when the insufflator has a flow setting of 18L/min or greater. During a procedure, this would result in pressure decrease in the abdomen. Unclear image due to poor abdominal distention is the hazardous situation associated with low gas pressure during a procedure |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect stocks and quarantine any affected units. A Stryker representative will contact the affected customers to arrange for the removal and replacement of the affected units. This action has been closed-out on 02/02/2017. |
| Contact Information |
02 9467 1175 - Stryker Australia |