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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00779-3
Product Name/Description	GUIDELINER Intravascular Guiding Catheter Previous ARTG: 180817 All remaining stock in the market
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/08/2012
Responsible Entity	Pyramed Pty Ltd
Reason/Issue	Guideliner Catheter is being recalled due to a regulatory compliance issue. Guideliner Catheter has now been cancelled from the Australian Register of Therapeutic Goods (ARTG) because it should have been classified as a Class III Medical Device, not a Class IIa Medical Device in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002. The Guideliner Catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a Class III device to provide assurance of its quality, safety and performance. In particular, the TGA has not been provided with appropriate data on the design verification and validation of the device necessary for a Class III classification.
Recall Action	Recall
Recall Action Instructions	Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).
Contact Information	1800 651 882 - Pyramed Pty Ltd