| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01156-1 |
| Product Name/Description |
Adult Circuit Tubing (Oxygen therapy delivery system)
Product Code: 900MR068
Lot Numbers: 110810 & 111020
ARTG Number: 129354 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Fisher and Paykel Healthcare has become aware that one batch of tubes supplied to Fisher and Paykel Healthcare may contain hole damage. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. |
| Recall Action |
Recall |
| Recall Action Instructions |
Fisher and Paykel is recalling affected product and is replacing it with unaffected tubing. |
| Contact Information |
1800 060 698 - Fisher & Paykel Healthcare |