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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01517-1
Product Name/Description	Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F Item Number: 10043 Lot Numbers: 19948645, 18836128, 19545073, 19793264, 19809517, 20024281 NV GUIDER CATHETER 90CM ST 7F Item Number: 10051 Lot Numbers: 18898135, 18898416 NV GUIDER CATHETER 90CM ST 8F Item Number: 10052 Lot Numbers: 18643117 ARTG Number: 146034
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/12/2017
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has initiated a lot specific product recall on Certain lots of Guider 7F and 8F product which may be at risk of degrading within their shelf-life period. The root cause of the issue is exposure of components to UV light while in storage between 2014 and October 2017. There have been no reports of injuries associated with this issue.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected product. This action was closed out on the 12/09/2018
Contact Information	02 9467 1175 - Strkyer Australia