Home / Recalls / Medical Devices
Smith & Nephew, Inc. recalls RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction devi
Recalled October 1, 2014 · FDA recall Z-2688-2014 · Smith & Nephew
Hazard
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. · FDA Class II
Units
2,142 units
Sold at
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.
Description
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Product
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →