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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00507-1
Product Name/Description	Flexi-Seal CONTROL Faecal Management System Product code: 411107 All lot numbers ARTG number: 163198
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	8/05/2014
Responsible Entity	Convatec Australia Pty Ltd
Reason/Issue	An internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal CONTROL Faecal Management System is not meeting performance requirements for this product. Specifically, the Auto-Valve has not been consistently performing relative to the inflation and deflation of the device’s retention balloon. In the event that the Auto-Valve does not perform properly related to inflation and deflation of the device’s retention balloon, there is the potential that medical intervention may be necessary. In accordance with the Instructions for Use supplied with the Flexi-SealTM ControlTM Faecal Management System, the following events could occur: - Leakage of stool around the device, and peri-anal skin breakdown; - Rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa; - Perforation of the bowel.
Recall Action	Recall
Recall Action Instructions	End users are advised to stop the use of all affected devices and return all affected products to their distributor for credit or replacement with unaffected product.
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