| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00567-1 |
| Product Name/Description |
Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)
Product Description: Packaging Box Set
Part Number: 2M86841
Batch Numbers: 330384.001 - 331661.002
Product Description: Hose Packaging
Part Number: 2M86791
Batch Numbers: 330384.001 - 331661.002
ARTG Number: 131796 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Drager has become aware of cases where prior to the use of the Disposable Ventstar Oxylog 2000 Ventilation Hoses, adhesive residue the size of a finger nail was found loose in the hose or the packaging around the hose; had teh hose been used with the residue in place it may have entered the patient's lungs. |
| Recall Action |
Recall |
| Recall Action Instructions |
Draeger is advising their customers to not use the hose system from the affected batches and to contact customer service to arrange for recovery and replacement. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |