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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00514-1
Product Name/Description	Suction Tube Sterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300 Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600 Multiple Batches ARTG Numbers: 173916 (Sterile) & 204281 (Non-sterile)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/06/2015
Responsible Entity	ConvaTec Australia Pty Ltd
Reason/Issue	An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. Specifically, the connector part for application to the suction devices in these LOTs, has failed to meet its required reliability. The connector parts of the specified LOTs have a higher probability to crack once applied to suction devices outlets.
Recall Action	Recall
Recall Action Instructions	Convatec is requesting end users to quarantine the affected product and return to their distributor for replacement or credit. This action has been closed-out on 11/08/2016.
Contact Information	03 9239 2737 ConvaTec