Medical device manufacturer, Kimberly-Clark issued a medical device safety alert concerning ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile.
Kimberly-Clark has determined that the package seam of the above mentioned products may not remain properly sealed to ensure that the contents of the package are sterile. Therefore, the affected products might not be sterile as labeled.
Kimberly-Clark further explained that the package includes a caution statement indicating 'Contents Sterile. Unless this package is opened or damaged.' The direct risk associated with this potential failure mode is that use of an affected non-sterile gown in surgery could lead to contamination of the surgical field. However, as the user inspects each package prior to use, the likelihood for use of a non-sterile gown in surgery is considered to be remote.
According to Kimberly-Clark, the affected lots have been distributed in Hong Kong. Kimberly-Clark advised the affected users to stop using the impacted product lots.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 July 2012