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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00994-1
Product Name/Description	Ethicon HARMONIC ACE+ 7 Laparoscopic Shears Product Codes: HARH23, HARH231, HARH36, HARH361, HARH45 and HARH451 Batches with expiration dates before 08-2020 ARTG Number: 118011
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/10/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	The manufacturer has determined that under extreme handling circumstances, damage, such as a hole, can occur in the Tyvek lid due to an interaction between the advanced haemostasis button and Tyvek, which would could compromise device sterility. The manufacturer has received no reports of adverse events for this issue.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical are advising users of alternative products to use. Users are advised to inspect stock and quarantine any affected product to be returned to Johnson & Johnson. This action has been closed-out on 05/12/2016.
Contact Information	1800 252 194 - Johnon& Johnson Medical Customer Service