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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01065-1
Product Name/Description	Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT)) Part Numbers: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258 Multiple Products and Lot Numbers affected ARTG Number: 149671
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/08/2016
Responsible Entity	Smith & Nephew Pty Ltd
Reason/Issue	Smith & Nephew have identified seal integrity failures on the folded Sterile Renasys Transparent Film pouches during transit testing. All the seal integrity failures identified during the testing occurred at the point where the Sterile Renasys Transparent Film pouches were folded during the packaging process. The loss of sterility has the potential to contribute to a local infection. To date, Smith & Nephew is not aware of any complaints reported in relation to this issue that has led to a local infection.
Recall Action	Recall
Recall Action Instructions	Smith & Nephew are advising users to inspect stock and quarantine all affected units. In the event that a Transparent Film is required for NPWT therapy, the responsible Health Care Professional should be consulted to determine an alternative Transparent Film or alternative treatment. Affected stock can be returned and replaced with unaffected product. This action has been closed out on 7/09/2018.
Contact Information	02 9857 3999 - Smith & Nephew