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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00603-1
Product Name/Description	Britepro Solo Single-Use Fiber Optic Laryngoscope Part number: 040-310, 040-310, 040-333, 040-333, 040-333, 040-333, 040-334, 040-334, 040-334, 040-344, 040-343 Lot number: 200600284, 200503144, 200101078, 191002181, 220301692, 200503144, 200600287, 200600288, 200700560, 201001784 Expiry date: 2025-05, 2025-04, 2024-12, 2024-09, 2027-04, 2025-04, 2025-05, 2025-05, 2025-06, 2025-09 ARTG 340622 (Flexicare Australia Pty Ltd - Rigid intubation laryngoscope, single-use)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/07/2024
Responsible Entity	Flexicare Australia Pty Ltd
Reason/Issue	Flexicare Ltd has been made aware of incidents that BritePro Solo Laryngoscope handles have failed to illuminate when preparing for intubation during emergency situations. As with all single-use BritePro Solo Laryngoscopes it is a requirement to carry out a pre-use illumination check. The method of detection is visual, and the user can ascertain if handle is illuminating while still in the packing, therefore not compromising the sterility.
Recall Action	Recall
Recall Action Instructions	Customers are advised to: - Locate and quarantine the devices with affected lot numbers. The lot number can be found on both the outer box label and the individual packaging. - Complete and return the Acknowledgment and Response Form so that return and credit/replacement of these devices can then be arranged.
Contact Information	0 450 977 007 - quality@flexicare.com - Flexicare Australia Pty Ltd