| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00394-1 |
| Product Name/Description |
Dräger Carina Ventilator
Serial Numbers: ASKM-0074; ASKM-0075; ASKM-0076; ASKM-0077; ASKM-0078; ASKM-0079; ASKM-0080; ASKM-0082; ASKM-0083; ASKM-0084; ASKM-0085; ASKM-0086; ASKM-0087; and ASKM-0088
ARTG Number: 140966
(Draeger Australia - Ventilator, adult) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Draeger has been made aware that one component in the valve assembly of the Carina Ventilator was not sufficiently cleaned by a supplier. Over time, this can result in the material of the valve assembly becoming corroded and can result in contamination of the breathing gas.
This issue was identified during production at Dräger. To date, no reports of adverse events have been received as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Draeger is advising customers to remove the potentially affected devices from use immediately to exclude any further risk to patients. Draeger will provide affected sites with loan devices to alleviate any delays and/or downtime.
Draeger will contact users (via Engineering Department) to schedule the replacement of the affected components.
This action has been closed out on the 21/11/2018. |
| Contact Information |
03 9244 7428 - Draeger Medical Australia |