RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

Reason: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

Code information: Model #'s 66800059, all lots since product launched 01/16/2009

Distribution pattern: Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.