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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01311-1
Product Name/Description	Clearify Visualization System (Laparoscopic Care Kit) Item Code: 21-345 Lot Numbers: P6E0016GX, P6E0049GX, P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX AND Lot Numbers beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D ARTG Number: 224957
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/10/2016
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Due to a potential compromise in the packaging, there is the possibility of a breach of the sterile barrier. The use of products with this packaging defect may increase the risk of infection. There have been no reports of serious injury associated with this issue.
Recall Action	Recall
Recall Action Instructions	Covidien is advising customers to quarantine and discontinue use of devices with the affected item codes and lot numbers. Covidien will arrange for the return of unused products from the affected item codes and lots, and will issue credit for the returned devices. This action has been closed out on 25/10/2018
Contact Information	02 9429 3148 - Covidien