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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00176-2
Product Name/Description Haemoband PLUS

All lots affected

ARTG Number: 136643
(Horten Medical - Ligator, haemorrhoid)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 13/03/2018
Responsible Entity Horten Medical Pty Ltd
Reason/Issue Horten Medical is re-issuing the Instructions for Use (IFU) document for the Haemoband Plus.

This Product Defect Correction was initiated as the Haemoband Plus, on one occasion, did not load the ligation band. There was no patient danger involved. As a result of this incident, Haemoband Surgical through Horten Medical have taken the decision to replace the Instructions for Use with an updated IFU, describing the procedure.
Recall Action Product Defect Correction
Recall Action Instructions Horten Medical is providing updated Instructions for Use, and undertaking user training.

This action has been closed out on 21/01/2021
Contact Information 02 9736 3425 - Customer Service Support