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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00618-1
Product Name/Description	Microcatheter SONIC 1.5F Product Code: SONIC1.5F25 Lot Number: 00268901 ARTG Number: 155392
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/05/2017
Responsible Entity	Getz Healthcare Pty Ltd
Reason/Issue	Getz Healthcare has been advised by their supplie, Balt Extrusion, that the manufacture, marketing, distribution, export and use of the Microcatheter SONIC 1.5F will be temporarily suspended. Modifications to SONIC 1.5F have been filed with the notified body in Europe but the device has been put on the market prior approval. (The manufacturer is awaiting final clearance from the notified body before resupply).
Recall Action	Recall
Recall Action Instructions	Getz Healthcare is advising users to inspect their stock and quarantine affected units. Users will be contacted to arrange for the return of their affected units for a credit note or replacement stock to be issued. This action has been closed out on 02/10/2018
Contact Information	02 9413 6204 - Getz Healthcare