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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00160-1
Product Name/Description DLP Single Stage Venous Cannula with Metal Tip (Intended for the collection of deoxygenated blood from the superior and/or inferior vena cava during cardiopulmonary bypass)

Model Numbers: 69324, 69328, 69331
Lot Numbers: 2012121362, 2012121364, 2012121005 and 2012121063
ARTG Number: 155002
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 20/02/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified the potential for uncharacteristically rough metal edges, to occur along the inner diameter of the metal tip side ports of the cannula.
Recall Action Recall
Recall Action Instructions Medtronic is asking customers to immediately quarantine all affected products and return it to Medtronic for credit.
Contact Information 02 9857 9378 - Medtronic Regulatory Affairs