Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00617-3 |
Product Name/Description |
Laryngoscope Handles (LED) (Item No 08-100) and Laryngoscope Fibre Optic Blades (Item No 08-101)
Laryngoscope Handles (LED) (Item No 08-100) ARTG number: 184682
Laryngoscope Fibre Optic Blades (Item No 08-101) ARTG number: 184681
All batches |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
2/07/2012 |
Responsible Entity |
|
Reason/Issue |
The ‘Cold Soak Disinfection’ section of the Instructions For Use requires the inclusion of a rinse step which is necessary post-disinfection with Gluteraldehyde / Cidex. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
IFU update |
Contact Information |
1800 687 605 - Chris Argent |