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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00524-1
Product Name/Description	Vitrectomy Cutter 20GA Vitrectomy Cutter and Irrigation Sleeve Part Number: NGP0020 Lot Number: CA06180 25GA Vitrectomy Cutter Part Number: NGP0025 Lot Number: CA06182 ARTG Number: 93352
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/04/2017
Responsible Entity	AMO Australia Pty Ltd
Reason/Issue	There is the possibility that due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.
Recall Action	Recall
Recall Action Instructions	AMO Australia is advising users to immediately stop using and remove from their inventory all affected lots of the Vitrectomy Cutter. AMO will arrange for return of affected product and replacement. This action has been closed-out on 16/03/2018.
Contact Information	1800 266 111 - AMO Australia Customer Support