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Smith & Nephew, Inc. recalls Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a
Recalled January 25, 2017 · FDA recall Z-1041-2017 · Smith & Nephew
Hazard
Lack of 510k clearance for design modification. · FDA Class II
Units
15,960 units in the US
Sold at
Nationwide
Description
Lack of 510k clearance for design modification.
Product
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →