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 |
|
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 |