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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00751-1
Product Name/Description	C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery) All lot numbers 10405513 and higher C-Qur Multiple Catalogue Numbers affected ARTG Number: 163310 C-Qur TacShield Catalogue Numbers: 31610, 31611, 31612, 31626, 31628, 31633, 31636, 31637, 31638, 31644 ARTG Number: 182852 C-Qur V-Patch Catalogue Numbers: 31200, 31201, 31202 ARTG Number: 174772
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/07/2013
Responsible Entity	Atrium Australia - Pacific Rim Pty Limited
Reason/Issue	Atrium Medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. This becomes evident if: - it becomes difficult to peel the mesh from the handling sleeve, or - the yellow coating material separating the mesh is retained on the clear plastic liner.
Recall Action	Recall for Product Correction
Recall Action Instructions	Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.
Contact Information	1800 605 824 - Atrium Australia Pacific Rim Customer Service