Lake Region Medical is supporting the implementation of a change in the process used to synthesize the PTFE used in its LUBRIGREEN™ and Blue PTFE coatings with its primary coatings supplier. The change is to eliminate the use of PFOA (perfluorooctanoic acid) which is a processing aid. The PFOA will be replaced by a more biocompatible processing aid. This change will have no effect on the formulation of the coatings and this is supported by the Analytical test report (see opposite). This change has been driven by the U.S. Environmental Protection Agency's PFOA Stewardship Program stipulating that processors of PTFE no longer make, buy or use PFOA by 2015. We are proud to announce an implementation schedule that meets this objective in 2013.
This change will be supported by a Technical pack from our internal validation of the change. Upon request, this pack will be provided to customers in advance of the cutover date to enable review & for potential queries. Should you require product samples with the new coating, please order no later than March 2012 in order to ensure supply as there is an approximate 10-week lead time on sample provisions.
The estimated timeline for implementation of the PFOA-free PTFE coating configurations is as follows:
Green PTFE customers: January 2013 cut-over date
Technical packet will be available July 2012
Blue PTFE customers: March 2013 cut-over date
Technical packet will be available September 2012
Lake Region Medical is formally notifying customers to which this change applies. All queries regarding this change will be handled by the Change Notification team at LakeRegionChangeNotification@lakeregionmedical.com. Lake Region appreciates your business. If there are any elements we can provide during this transition, please don't hesitate to contact the Change Notification team at the provided e-mail. Thank you for the opportunity to serve you.