Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00586-1
Product Name/Description ReTurnBelt wipeable

Article Numbers: 6133,6134,6135,6136

All Belts in Lot 1402S

Distributed during 2014 and until March 2015

ARTG Numbner: 144735
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/07/2015
Responsible Entity Active Medical Supplies Pty Ltd
Reason/Issue Handicare received two complaints stating that while demonstrating the function of ReTurnBelt, when exposed to high load, the strap ripped at the heat welded seam.
This action was undertaken prior to notifying the TGA.
Recall Action Recall
Recall Action Instructions Handicare AB requested all belts with the affected lot number to be returned. Handicare AB through Active Medical is refunding the amount paid.
Contact Information 1800 267 267 - Active Medical