| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00916-1 |
| Product Name/Description |
Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)
Part Numbers: PF-DPC-High, PF-DPC-Low
Lot Numbers: HF1402035, HF1404043, LF1402030, LF1405023
ARTG Number: 147794 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Vapotherm Inc. has received a small number of complaints involving a defect in the Disposable Patient Circuit Delivery Tube. The defect allows water to leak into the centre lumen of the delivery tube, the gas line to the patient. The fault condition is easily detectable and typically occurs while the device is coming up to the set temperature and is easily visible when following the Precision Flow instructions for use, which requires that the cannula be connected to the patient only after the set temperature is reached. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to check their stock immediately to determine if they have any affected product. Customers are advised to return the affected stock to Surgical Specialties Pty Ltd. This action has been closed-out on 10/05/2017. |
| Contact Information |
1300 665 884 - Surgical Specialties Customer Service Department |