| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00437-1 |
| Product Name/Description |
Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits
Affected model numbers / lots numbers
ARTG Numbers: 129354 & 141298 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
FPH is issuing this recall notice because it has received customer reports relating to certain lot numbers of certain models of Nasal CPAP Prongs detaching from the FPH FlexiTrunk Nasal Tubing, especially in the presence of mucous and/or moisture. In the event of the Affected Prongs detaching from the Nasal Tubing, therapy is likely to be interrupted. This may lead to a patient becoming hypoxic. |
| Recall Action |
Recall |
| Recall Action Instructions |
FPH is requesting their customers to identify any units form the affected lot and destroy them. An FPH Representative can assist in sourcing a replacement product. |
| Contact Information |
03 9879 5022 - Fisher & Paykel Healthcare |