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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 Oliver Medical Pty Ltd
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