Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT)) 의 리콜

Recall

RC-2016-RN-01065-1

Class II

2016-08-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01065-1

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.

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.