FDA-Device2014-10-01Class II
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.
Smith & Nephew, Inc.
Hazard
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Sold states
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.
Affected count
2,142 units
Manufactured in
970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2688-2014Don't want to check this manually?
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