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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00166-1
Product Name/Description	Edi Catheter (nasogastric feeding tube) Edi Catheter,6Fr,49cm,PHT free 5pcs/pkg Article Number: 6685775 Edi Catheter, 6Fr, 50cm, PHT free 5pcs/pkg Article Number: 6685777 Edi Catheter,8Fr,100cm,PHT free 5pcs/pkg Article Number: 6685780 Edi Catheter,8Fr,125cm,PHT free 5pcs/pkg Article Number: 6685782 Edi Catheter,12Fr,125cm,PHT free 5pcs/pkg Article Number: 6685787 Edi Catheter,16Fr,125cm,PHT free 5pcs/pkg Article Number: 6685790
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/02/2014
Responsible Entity	Maquet Australia Pty Ltd
Reason/Issue	Following the report of an Edi Catheter disintegrating in a patient after 17 days of use Maquet has decided to provide the Edi Catheter with its own user's manual. The Edi Catheter IFU states that the catheter can only be in use for a maximum of 5 days.
Recall Action	Recall for Product Correction
Recall Action Instructions	Maquet is advising end users that the instructions for use will be provided with the Edi catheter and reiterating that the device can only be in use for up to 5 days.
Contact Information	1300 304 372 - Maquet Australia Pty Ltd