Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01234-1
Product Name/Description	FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits All lot Numbers ARTG Number: 170275
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	27/11/2014
Responsible Entity	Scott Health and Safety
Reason/Issue	Scott Safety has been advised by the supplier, Pacsource, of the ‘10 ml Normal Saline for Irrigation’ with batch number 1T2324002 included in the kits may not be sterile after failing the test for sterility undertaken by the TGA.
Recall Action	Recall
Recall Action Instructions	Scott Safety is recalling all affected First Aid Kits and requesting that these kits should be returned to them immediately. Scott Safety will inspect and replace ‘10 ml Normal Saline for Irrigation’ with alternate component that has already been secured. All new stock will be clearly marked with a QC sticker next to the barcode. This action has been closed-out on 18/03/2016.
Contact Information	02 8718 2191 - Scott Safety