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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00328-1
Product Name/Description	Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft Cook Biodesign 1-Layer Tissue Graft Model Numbers: C-SLH-1S-2X3, C-SLH-1S-7X10, SLH-1S-7X10 Cook Biodesign 4-Layer Tissue Graft Model Numbers: C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, SLH-4S-2X3, SLH-4S-3.5X5, SLH-4S-4X7, SLH-4S-7X10, SLH-4S-7X20 ARTG Number: 153047
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/04/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical is instigating a change in the Intended Use wording of the product Instructions For Use (IFU). This change is in response to the report of two potential adverse events during use in urological or gynecological procedures. This change will provide clarification of the product's intended use, with the addition of the following statement in the IFU: "This device is not intended for use in urological or gynaecological procedures".
Recall Action	Recall for Product Correction
Recall Action Instructions	Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update. This action has been closed out on 13/11/2018
Contact Information	1800 777 222 - Cook Medical