Brennen Skin Graft Mesher - 4.5 and 6.5 inch 의 리콜

Recall

RC-2017-RN-00536-1

Class II

2017-05-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00536-1

Resulting from a post-market internal investigation, mölnlycke has identified a potential safety issue regarding the current sterilisation validation for the brennen skin graft mesher. with the current sterilisation instructions contained in the instructions for use (ifu), the sterility of the mesher cannot be guaranteed following a sterilisation cycle carried out according to those instructions. given the sterility of the brennen skin graft mesher cannot be guaranteed there is a risk for possible contamination, which may lead to infection. mölnlycke confirms that no product, patient or user complaints have been reported to date for products in australia regarding this issue.

Mölnlycke is advising users to immediately stop using the Brennen Skin Graft Mesher and apply the tag (i.e. label) provided by Mölnlycke to the device, or otherwise remove the device from service using applicable labelling and/or quarantine measures under the respective in house quality management system. The tag supplied states that the device is out of service and should not be used. Once the new sterilisation parameters have been confirmed by the manufacturer, through further validation testing during May, Mölnlycke will send users the updated IFU defining the new Sterilisation Procedure. This is estimated to occur in June 2017.