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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00284-1
Product Name/Description 5mm ENDOPATH XCEL Trocars with Optiview Technology

Bladeless 5x100 Stability
Product Code: 2B5LT
Batch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004G

Bladeless 5x75 Stability
Product Code: 2B5ST
Batches: P4T745, P4T906, P4T91H, P4TA6O, P4TD0G

Sleeve 5x100 Stability
Product Code: 2CB5LT
Batches: P4T636, P4T63G, P4T708, P4T89N, P4TC53, P4TD1Y, R4003L, R4005Z

Sleeve 5x75 Stability
Product Code: 2CB5ST
Batches: P4T686, P4T99K,P4T79A, P4TD2D

ARTG 108472, 108482
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/04/2018
Responsible Entity Johnson & Johnson Medical Pty Ltd
Reason/Issue Johnson & Johnson Medical has been advised that the manufacturer, Ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm ENDOPATH XCEL Trocars with Optiview Technology.
To date, no injuries have been reported as a result of this issue.
Recall Action Recall
Recall Action Instructions Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.

This action has been closed out on 09/08/2019
Contact Information 02 9815 4000 - Johnson & Johnson Medical