Medical device manufacturer, Kimberly-Clark Corporation issued a medical device safety alert concerning 9in. X 9in. (23cm X 23cm) square sized KIMGUARD Container Filters. The affected product code is 68509 and the affected lot numbers are MF1279XXX, MF1287XXX, MF1288XXX.
According to the manufacturer, some individual container filter units from the above product lots might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. Complaints received so far involved defects that were identified prior to use of possibly affected instruments or supplies on patients.
Kimberly-Clark stressed that standard practice involves inspecting the sterilization container and filter for sterility breaches prior to use. If the defect is not detected upon standard inspection, contamination of surgical instruments and supplies within the container could be resulted.
Kimberly-Clark Asia Pacific Health Care confirmed that the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 March 2013