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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00485-1
Product Name/Description Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters

Excelsior SL-10 150CM 2 TIP
Excelsior 1018 Pre-shaped 45 150CM
Excelsior SL-10 Pre-shaped 45 150CM
Excelsior SL-10 Pre-shaped 90 150CM
Excelsior SL-10 Pre-shaped J 150CM

Catalogue Numbers: 168189, 144190, 168190, 168191, 168192

Lot Numbers: 17026669, 17013156, 17013021,17026849, 17030892, 17045869, 17045959, 17046094, 17046274, 17046229

ARTG Numbers: 177031, 149440, 147430
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/06/2015
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has become aware that certain lots of the above Excelsior SL-10/Excelsior 1018 microcatheters have incorrect product expiry dates printed on the packaging. The earliest expiration date of the affected products is May 2016. In the event these products remain in the market after the labelled expiry date, there is a potential hazard that patients exposed to this product may experience severe health consequences.
Recall Action Recall
Recall Action Instructions Stryker is requesting their customers to quarantine any affected lots on hand. Any affected items will be removed by the Stryker Representative and customers will be provided with unaffected replacement stock. This action has been closed-out on 18/08/2016.
Contact Information 1800 803 601 RAQA Co-ordinator