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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00321-1
Product Name/Description	SECOV150 / SECOV105 Item numbers: SECOV150, SECOV150, SECOV150, SECOV150, SECOV105, SECOV105, SECOV150, SECOV105, SECOV105, SECOV105, SECOV150, SECOV150 Serial numbers: 5-230202-086, 5-230202-087, 5-230202-088, 5-230202-089, 4-220416-053, 4-220416-067, 5-230608-076, 4-220416-068, 4-220416-069, 4-220416-070, 5-230729-036, 5-230729-037 ARTG 92656 (FAIRMONT MEDICAL PRODUCTS PTY. LIMITED Heating unit, pad, electric, system)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/04/2024
Responsible Entity	Fairmont Medical Products Pty Ltd
Reason/Issue	SOF and COV applied parts manufactured from May 2022 to October 2023 may have internal damaged electrical insulation at a few distinct locations. The root cause is an error in the manufacturing process of the heating element. The damage could lead to localised overheating. This was identified during internal investigation after a single reported adverse event in which a patient received a burn approximately 3 cm in diameter. This action was undertaken prior to TGA notification.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers were advised to inspect, and quarantine affected stock. Fairmont Medical has advised that the Adapters were delivered to the customers during February 2024.
Contact Information	03 9720 8840 – Harrison Verschuur